EPA (Environmental Protection Agency)
1 records
epa_echo
1 records
fda
281 records
FDA Drug Recall: Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syr
2025-09-03
Class II — Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
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FDA Drug Recall: RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda
2025-08-13
Class II — CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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FDA Drug Recall: Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San
2025-08-13
Class II — CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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FDA Drug Recall: Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, I
2025-08-13
Class II — CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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FDA Drug Recall: Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per
2025-05-07
Class II — Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution...
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FDA Drug Recall: LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3
2023-11-29
Class I — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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FDA Drug Recall: LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetra
2023-11-29
Class I — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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FDA Drug Recall: LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottle
2023-11-29
Class I — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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FDA Drug Recall: LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 m
2023-11-29
Class I — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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FDA Drug Recall: LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dr
2023-11-29
Class I — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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FDA Drug Recall: LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL O
2023-11-29
Class I — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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FDA Device Recall: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter P
2022-12-14
Class II — Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, ...
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FDA Device Recall: Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.
2022-12-14
Class II — Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, ...
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FDA Device Recall: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter
2022-12-14
Class II — Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, ...
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FDA Device Recall: Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended fo
2022-12-14
Class II — Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, ...
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FDA Drug Recall: Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens
2022-05-25
Class II — TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
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FDA Drug Recall: Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefi
2022-05-25
Class I — TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
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FDA Drug Recall: Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens,
2022-05-25
Class II — TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
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FDA Recall: Cardinal Health — Class II
20211222
Potential for open packaging seals compromising the sterility of the surgical gowns | Product: RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
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FDA Recall: Cardinal Health — Class II
20211222
Potential for open packaging seals compromising the sterility of the surgical gowns | Product: RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
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FDA Recall: Cardinal Health — Class I
20210901
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. | Product: Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Cod...
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FDA Recall: Cardinal Health Inc. — Class II
20210630
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which m | Product: OPTICHAMBER DIAMOND SPACER WITH LARGE ...
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FDA Device Recall: RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
2021-12-22
Class II — Potential for open packaging seals compromising the sterility of the surgical gowns
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FDA Device Recall: RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
2021-12-22
Class II — Potential for open packaging seals compromising the sterility of the surgical gowns
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FDA Device Recall: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SK
2021-12-22
Class II — Potential for open packaging seals compromising the sterility of the surgical gowns
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FDA Device Recall: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
2021-12-22
Class II — Potential for open packaging seals compromising the sterility of the surgical gowns
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FDA Device Recall: Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
2021-12-22
Class II — Potential for open packaging seals compromising the sterility of the surgical gowns
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FDA Device Recall: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
2021-12-22
Class II — Potential for open packaging seals compromising the sterility of the surgical gowns
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FDA Device Recall: Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 888
2021-09-01
Class I — Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
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FDA Device Recall: Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 88
2021-09-01
Class I — Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
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FDA Device Recall: Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8
2021-09-01
Class I — Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
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FDA Device Recall: OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
2021-06-30
Class II — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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FDA Device Recall: ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
2021-06-30
Class II — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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FDA Device Recall: FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
2021-06-30
Class II — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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FDA Device Recall: FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
2021-06-30
Class II — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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FDA Device Recall: DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
2021-06-30
Class II — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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FDA Device Recall: ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
2021-06-30
Class II — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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FDA Device Recall: VAPORIZER VICKS 1.5GAL Item Number: 2354942
2021-06-30
Class II — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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FDA Drug Recall: Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Onl
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perr
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT O
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only,
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manuf
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefil
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 5965
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by:
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWD
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Ster
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for:
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Te
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation On
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Redu
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodi
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tab
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablet
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-29
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-S
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 498840
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL -
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Dro
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-3
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, A
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactu
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distri
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-0
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardin
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manu
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for:
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg d
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation po
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Ma
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufa
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhala
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic P
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Labor
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhale
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPEN
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-034
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIA
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UP
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufact
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 O
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-0
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Take
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-02
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactu
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nep
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Per
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Pa
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutrition
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by:
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B1
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydr
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactur
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYD
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oselta
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Man
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for P
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 3
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OP
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each ta
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK)
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 6
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bo
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Applica
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only N
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily dose
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactur
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10;
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL -
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: HYDROCORTISONE 1% 30gm cream
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx onl
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured b
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DR
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, M
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufact
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, M
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: TRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; N
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and conc
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolam
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonid
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufacture
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement C
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary S
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglu
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only D
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (AN
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer I
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 605
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Man
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 ca
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAP
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; T
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for:
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-105
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
View Source
FDA Drug Recall: CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufa
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 6
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottl
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg
2021-06-02
Class II — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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FDA Drug Recall: Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per
2021-04-07
Class III — Temperature Abuse
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FDA Recall: Cardinal Health Inc. — Class II
20200603
The feeding spike sets may leak at the interface of the tube and spike connector. | Product: Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
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FDA Recall: Cardinal Health Inc. — Class II
20200603
The feeding spike sets may leak at the interface of the tube and spike connector. | Product: Kangaroo 924 Safety Screw Spike Set, Product Code 775759
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FDA Recall: Cardinal Health Inc. — Class II
20200527
Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abuse | Product: Professional Urine Drug Control, Item ...
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FDA Recall: Cardinal Health — Class II
20200212
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. | Product: AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
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FDA Recall: Cardinal Health — Class II
20200212
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. | Product: AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
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FDA Recall: Cardinal Health — Class II
20200212
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. | Product: AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
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FDA Recall: Cardinal Health — Class II
20200212
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. | Product: AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
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FDA Device Recall: Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
2020-06-03
Class II — The feeding spike sets may leak at the interface of the tube and spike connector.
View Source
FDA Device Recall: Kangaroo 924 Safety Screw Spike Set, Product Code 775759
2020-06-03
Class II — The feeding spike sets may leak at the interface of the tube and spike connector.
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FDA Device Recall: Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Produ
2020-06-03
Class II — The feeding spike sets may leak at the interface of the tube and spike connector.
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FDA Device Recall: Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Prof
2020-05-27
Class II — Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis o...
View Source
FDA Device Recall: AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
View Source
FDA Device Recall: AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
View Source
FDA Device Recall: AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: ROYALSILK LARGE, Gown. Item Code 9518
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: ROYALSILK XLARGE, Gown. Item Code 9548
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
View Source
FDA Device Recall: GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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FDA Device Recall: AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
View Source
FDA Device Recall: AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
View Source
FDA Device Recall: AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
View Source
FDA Device Recall: AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
View Source
FDA Device Recall: AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
View Source
FDA Device Recall: AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
View Source
FDA Device Recall: AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
2020-02-12
Class II — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
View Source
FDA Device Recall: Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System
2020-01-01
Class II — Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
View Source
FDA Device Recall: BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Pla
2016-10-12
Class II — Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability of Vinyl Plastic Film. The standard defin...
View Source
FDA Device Recall: The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampli
2016-09-07
Class II — Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has identified a potential customer/user sa...
View Source
FDA Device Recall: Gomco Style Circumcision Clamp Trays is an instrument used to compress the fores
2016-04-13
Class II — Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.
View Source
FDA Device Recall: Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal us
2015-10-28
Class II — Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by t...
View Source
FDA Drug Recall: Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister
2015-04-22
Class III — Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was pack...
View Source
FDA Recall: Cardinal Health — Class II
20130130
The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet. | Product: Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC...
View Source
FDA Device Recall: Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity;
2013-04-03
Class II — Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
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FDA Device Recall: Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity;
2013-04-03
Class II — Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
View Source
FDA Device Recall: Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable N
2013-04-03
Class II — Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
View Source
FDA Food Recall: Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, R
2013-01-30
Class II — The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet.
View Source
fda_adverse
4 records
FDA AE Manufacturer: CARDINAL HEALTH
Drug adverse event reporter — Product: CALCIUM CARBONATE
View Source
FDA AE Manufacturer: CARDINAL HEALTH, INC.
Drug adverse event reporter — Product: ASPIRIN
View Source
FDA AE Manufacturer: Cardinal Health,Inc.
Drug adverse event reporter — Product: LIDOCAINE
View Source
FDA AE Manufacturer: Cardinal Health, Inc
Drug adverse event reporter — Product: ISOPROPYL ALCOHOL
View Source
ftc
2 records
FTC Case: Cardinal Health, Inc, In the Matter of
FTC enforcement action — tags: enforcement
View Source
lobbying
4 records
Lobbying Client: CARDINAL HEALTH, INC.
Lobbied by BAKER & HOSTETLER LLP — Healthcare products and services company
View Source
Lobbying Client: CARDINAL HEALTH, INC.
Lobbied by BROWNSTEIN HYATT FARBER SCHRECK, LLP — Health care services company
View Source
Lobbying Client: CARDINAL HEALTH, INC.
Lobbied by POWERS PYLES SUTTER & VERVILLE, P.C. — Health care policy issues related to company products and services
View Source
nppes
1 records
ny_corps
1 records
NY Corp: CARDINAL HEALTH LLC
2023-04-26
DOMESTIC LIMITED LIABILITY COMPANY | County: Westchester | Jurisdiction: New York
View Source
ny_spills
6 records
NY Spill: CARDINAL HEALTH — unknown material
2007-03-10
MONTGOMERY, Orange County | 0.00 Gallons of unknown material
NY Spill: CARDINAL HEALTH — unknown material
2007-03-10
MONTGOMERY, Orange County | 0.00 Gallons of unknown material
NY Spill: CARDINAL HEALTH — unknown material
2007-03-10
MONTGOMERY, Orange County | 0.00 Gallons of unknown material
NY Spill: CARDINAL HEALTH — diesel
2005-02-03
DEWITT, Onondaga County | 0.00 Gallons of diesel
NY Spill: CARDINAL HEALTH — diesel
2005-02-03
DEWITT, Onondaga County | 0.00 Gallons of diesel
NY Spill: CARDINAL HEALTH — diesel
2005-02-03
DEWITT, Onondaga County | 0.00 Gallons of diesel
SEC EDGAR
1 records
sec_efts
1 records
SEC Filing: CARDINAL HEALTH INC
2024-05-02
SEC EDGAR filing — Forms: 10-Q — Query: pharmaceutical drug
View Source
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