fda
383 records
FDA Drug Recall: HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, St
2018-02-21
Class I — Non-Sterility
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FDA Drug Recall: HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Phar
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, S
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intratheca
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Pre
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Steril
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxv
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofe
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of Americ
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy o
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Ster
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Ph
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Re
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Comp
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Phar
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The C
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compoundi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compo
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, Knox
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knox
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature, T
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of Amer
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxv
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile -
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Kn
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dos
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 m
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preser
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of A
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of Amer
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharma
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix (30/0.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy o
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temper
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Magnesium Sulfate 500 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, T
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, The Compoun
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Pre
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Co
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Co
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix (37.5/2/20) Injectable, The Compounding Pharmacy of America, Knoxville,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Lidocaine 1% Injection, The Compounding Pharmacy of America, Knoxville, TN
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix (30/1/22) (MFG) Injectable, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxv
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Com
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preserva
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compou
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 2,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The C
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Zinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding P
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Com
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 80 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compoundi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathec
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of Americ
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile, Keep Frozen, The Compoundi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 5,000 IU/ml + Methylcobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Ster
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hyaluronidase 150 units/ml Injection, ml, Sterile, Preservative Free, Refrigerat
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 10,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compoundin
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Phar
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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FDA Drug Recall: Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The C
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 7,500 mcg/ml, + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Pr
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy o
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigera
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compoun
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile, R
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: LIPO-EXTREME Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compoun
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temp
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Oxytocin 100 units/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Comp
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Sermorelin/GHRP2 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigera
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compou
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, The Compounding Phar
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 30 mg/ml + Bupivacaine 5 mg/ml Solution, Sterile-Preservative Free, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 15 mg/ml Solution, Steri
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compound
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Ph
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml Multi-Dose Vial, Ste
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of A
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution, Sterile-Preservative Fre
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compoun
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Refri
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 2,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile - Pre
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 8,000 mcg/ml, + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Pr
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Glutathione 200 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Comp
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix ST2/LIDO2/PGE2 0.2/0.1/0.04, Injectable, The Compounding Pharmacy of Ame
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 1 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compo
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 45 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Pre
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Lipotropic B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compo
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative Fre
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 5,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Pre
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MEGA-BURN, Winning at Weight Loss Formula Injectable, Multi-Dose Vial, Sterile,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 70 mg/ml+Fentanyl 16,000 mcg/ml+Bupivacaine 15 mg/ml+Clonidine 1,0
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 2,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydroxyprogesterone Caproate (17-HP) 250 mg/ml Injectable, Multi-Dose Vial, Room
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Nandrolone Decanoate 250 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temp
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: LIPOLEAN + Ascorbic Acid 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Tem
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml + Bupivacaine 2.5 mg/ml Solution, Sterile-Preservative Free, T
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxv
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 70 mg/ml + Clonidine 1,100 mcg/ml Solution, Sterile-Preservative Free,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: LIPO-DEN MODIFIED Injection, Multi-Dose Vial, Sterile, Room Temperature, The Com
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix T-102 (17.65 mg/0.59 mg/10 mcg) Injectable, The Compounding Pharmacy of
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 30 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Tempe
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 2,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Com
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,100 IU/ml + Methylcobalamin 0.5 mg/ml Injection, ml Multi-Dose Vial, Steri
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml Injection, Multi-Dose
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Methylcobalamin 5,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (20/1/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 35 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MIC-B COMPLEX Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compou
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 12.5 mg/ml Solution, Sterile-Preservative Free, The Compounding Ph
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone USP Aqueous 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Tem
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., K
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (30/1/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution, Sterile,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 200 m
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 11,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compoundin
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Comp
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knox
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 45 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvill
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 ml Injection, Multi-Dose Vial, Steril
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrigera
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,200 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable, Sterile
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Zinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Com
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Acetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compoundin
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America, Kn
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 4,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Steril
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxv
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix Injectable, The Compounding Pharmacy of America, Knoxville, TN
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The C
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 33 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compoun
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Ph
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharm
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (37.5/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxv
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Phar
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Tempe
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of Americ
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (30/1/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxvi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 70 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 15 DAY KIT, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (15 mg/0.5 mg/5 mcg) Injectable, Sterile, Keep Frozen, The Compounding P
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Tempe
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 20 mg/ml + Clonidine 400 mcg/ml Solution Sterile-Preservative Free, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 60 mg Anastrazole 4 mg Pellet, Sterile, The Compounding Pharmacy of
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix AT-1 (8 mg/2 mg/0.2 mg) Injectable, The Compounding Pharmacy of America,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 75 mg and B12 6 mg Pellet, Sterile, The Compounding Pharmacy of Ame
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 30 mg/ml + Baclofen 10 mcg/ml Solution, Sterile-Preservative Free, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix ST9A (30 MG/2 MG/80 MCG) Injectable, The Compounding Pharmacy of America
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 40 DAY KIT, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Cholecalciferol 100,000 IU /ml Injectable, ml Vial, Sterile, Refrigerate, The Co
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MIC-B12+B6 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compoundin
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml +Fentanyl 1,000 mcg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MEGA-BURN IV Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compoun
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Comp
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Polidocanol 1% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compoundin
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 20 mg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile-Pr
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Cholecalciferol 500,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Com
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Fre
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (30/1/22) Injectable, The Compounding Pharmacy of America, Knoxville, T
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Vitatrim Active Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compoundi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Prese
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 72.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxv
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Myers Cocktail Injection, Sterile, Refrigerate, The Compounding Pharmacy of Amer
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 200 mg/ml Anastrazole 2 mg/ml Injection, Multi-Dose Vial,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix T-101 (17.65 mg/0.59 mg/5.9 mcg) Injectable, The Compounding Pharmacy of
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compoundi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MYO-DEN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding P
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Tempera
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 10,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Pres
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Tempe
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydroxocobalamin 10,000 mcg/ml Injection, Multi-Dose Vial, sterile, Refrigerate,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: 5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 50 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Kno
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml + Ropivacaine 5 mg/ml +Baclofen 20 mcg/ml Solution, Sterile, P
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigera
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix ST1 (30 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of Americ
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Co
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 42 DAY KIT, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Calmme Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding P
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 0.25 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Co
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hyaluronic Acid Sodium 32 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, S
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Bi-Mix (20/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of Amer
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (22.5/0.83/8.3) Injectable, Sterile, Keep Frozen, The Compounding Pharma
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Bi-Mix Medium (30/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 40 mg/ml (10 ml Sesame Oil), Injection, Multi-Dose Vial,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Methylcobalamin 1,000 mcg/ml + Hydroxocobalamin 1,000 mcg/ml Injectable, Preserv
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidin
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Fre
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 5,000 mcg/ml + Baclofen 250 mcg/ml Intrathecal Solution, Sterile - Pres
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Quad-Mix 2 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Ph
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: LIPOLEAN Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compoundin
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Cholecalciferol 50,000 U
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml Injectable, Multi-Dos
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 5,000 mcg/ml + Clonidine 3,000 mcg/ml Intrathecal Solution, Sterile - P
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MEGA-BURN Injectable ROCK CREEK, Multi-Dose Vial, Sterile, Room Temperature, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Polidocanol 5% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 20 mg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative F
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compo
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (30/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 3 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Pres
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding P
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Lidocaine 2% with Epinephrine 1:100,000 (Buffered) Vial, Sterile, Refrigerate, T
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 200 mg Anastrazole 9 mg Pellet, Sterile, The Compounding Pharmacy o
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix MEDIUM (15/0.5/5) (MFG) Injectable, The Compounding Pharmacy of America
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 36 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile- Preservative Free, T
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding P
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (30/0.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Phar
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 5 mg/ml Injection, Multi-Dose
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Propionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temp
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Selenium 200 mcg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 20 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharm
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal S
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hyaluronic Acid Sodium 35 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, S
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofe
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxvi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix ST9A (30 mg/2 mg/80 mcg) Injectable, The Compounding Pharmacy of America
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Quad-Mix 1 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Ph
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 Injectable, The Compounding Pharmacy of
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 3,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Lipo-DEN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compoun
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 mg/ml Solution, Steril
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (30/1/10) Injectable, The Compounding Pharmacy of America, Knoxville, TN
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperatu
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 25 mg/ml + Baclofen 100 mcg/ml Solution, Sterile-Preservative Free, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 200 mg Anastrazole 1 mg Pellet, Sterile, The Compounding Pharmacy o
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Magnesium Chloride 200 mg/ml (20%) Injection, Multi-Dose Vial, Sterile, Refriger
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 70 mg/ml +Fentanyl 16,000 mcg/ml + Bupivacaine 12 mg/ml + Clonidin
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofe
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hyaluronidase 175 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The C
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidin
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (30/1/10) (MFG) Injectable, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperatur
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, T
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (30/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compo
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix T-106 (30 mg/1 mg/25 mcg) Injectable,The Compounding Pharmacy of America
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix SUPER (28 mg/0.9 mg/37 mcg) Injectable, Sterile Keep Frozen, The Compoun
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: SUPER LIPO Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compoundi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Betamethasone Sodium Phosphate (10 ml) 30 mg/ml Injectable, The Compounding Phar
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Fre
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Sodium Tetradecyl Sulfate 5% Injectable, Multi-Dose Vial, Sterile, Refrigerate,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 5,000 IU/ml + Methylcobalamin 500 mcg/ml Injection, Multi-Dose Vial, Sterile
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Cyanocobalamin 1,000 mcg/ml + B-Complex 100 mg/ml, ml, Multi-Dose Vial, Sterile,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Sufentanil 45 mcg/ml + Bupivacaine 5 mg/ml Solution, Sterile=Preservative Free,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Lipotropic Methyl B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 80 mg/ml + Clonidine 1,800 mcg/ml + Baclofen 730 mcg/ml Intratheca
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal So
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preserva
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Injection, Multi-Dose Vi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,000 IU/ml + Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Ster
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 30 DAY KIT, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Lipovicine-Choline 100 mg/ml-Acorbic Acid 45 mg/ml Injectable, Multi-Dose Vial,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Pyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrige
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compo
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 5,000 mcg/ml, + Bupivacaine 15 mg/ml Intrathecal Solution, Sterile - Pr
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 70 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 42 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperat
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,000 IU/ml + Methylcobalamin 1 mg/ml Injection, Multi-Dose Vial, Sterile, R
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 150 mg/ml Injection Multi-Dose Vial, Sterile, Room Temper
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 40 mg/ml + Fentanyl 2,000 mcg/ml Solution, Sterile-Preservative Free, T
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free, The Compounding Phar
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compound
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Methylcobalamin 10,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (10/0.174/16) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 220 mg/ml Injection, Multi-Dose Vial, Sterile, Room Tempe
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone USP (10 AQUEOUS) 100 mg/ml Injection, Multi-Dose Vial, Sterile, Roo
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MEGA-BURN* Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compoundi
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Methylcobalamin 4,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 65 mg/ml Solution, Sterile-Preservative Free, The Compounding Phar
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Tempera
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preserva
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 mg/ml, Solution, Ste
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix ST9C (30 mg/2 mg/120 mcg) Injectable, The Compounding Pharmacy of Americ
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding P
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy of
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmacy o
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (17.7 mg/1 mg/10 mcg) Injectable, Sterile, Keep Frozen, The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone Cypionate 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temper
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compou
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, The Compounding Pharmacy of America
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,000 IU/ml + MIC B-12 Injection, Multi-Dose Vial, Sterile, Refrigerate, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Lipotropic B-12 II* + Lidocaine Injection, Multi-Dose Vial, Sterile, Room Temper
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, Th
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: HCG 1,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix (20/2.5/20) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Prese
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature, The C
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Vancomycin 25 mg/ml Ophthalmic Solution, Single Dose, Sterile, Keep Frozen, The
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable, The Compounding Pharmacy of
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Prese
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intratheca
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, Keep Fro
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: MEGA-BURN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compoun
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvil
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose V
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate,
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Testosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxv
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
FDA Drug Recall: Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxv
2015-09-23
Class II — Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
View Source
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