Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIFIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIEnoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIDoxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIDonepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIDonepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIDicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIColgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IICITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IICHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIBumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IILow Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIAsmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIAripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIAMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIAMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIIpratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugGlaxoSmithKline LLCClass IIIANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
- 2023-12-27FDA-DrugBlistex IncClass IOdor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392.
Chemical contamination: Presence of benzene
- 2023-12-27FDA-DrugNoah's Wholesale LLCClass ITHE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
- 2023-12-27FDA-DrugFagron, IncClass IINYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
- 2023-12-27FDA-DrugFagron, IncClass IINYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
- 2023-12-27FDA-DrugFagron, IncClass IINYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
- 2023-12-27FDA-DrugFagron, IncClass IINYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
- 2023-12-27FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass IPhenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
Failed Content Uniformity Specifications
- 2023-12-27FDA-DrugPrivate Label Partners, Inc.Class IISelenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
CGMP Deviations: Stability data does not support expiry date.
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