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.
- 2024-01-10FDA-DrugSeaway Pharma Inc.Class IINasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
- 2024-01-10FDA-DrugAzurity Pharmaceuticals, Inc.Class IIIEprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
- 2024-01-03FDA-DrugTCP HRB ACQUISITON LLCClass ISure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06
Chemical contamination: Presence of benzene
- 2024-01-03FDA-DrugTCP HRB ACQUISITON LLCClass ISure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5517-06
Chemical contamination: Presence of benzene
- 2024-01-03FDA-DrugTCP HRB ACQUISITON LLCClass IBrut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070108, NDC 41595-7103-2), Distributed by Idelle Labs, Ltd. El Paso, TX 79912 USA
Chemical contamination: Presence of benzene
- 2024-01-03FDA-DrugMeta HerbalClass IMagnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
- 2024-01-03FDA-DrugLegacy Pharmaceutical Packaging LLCClass IISertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
- 2024-01-03FDA-DrugAnazaoHealth CorporationClass IIThiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.
Presence of Particulate Matter.
- 2024-01-03FDA-DrugAnazaoHealth CorporationClass IIB-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3
Presence of Particulate Matter.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIInhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIWarfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIWarfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IITriamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IITerconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IISPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIRIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIRicola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIPropranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIPredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IINyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIMetoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIMeloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IILithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IILisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IILillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IILeader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIJardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIHydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIFOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- 2024-01-03FDA-DrugCARDINAL HEALTHCAREClass IIFluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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