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.
- 2024-11-06FDA-DrugBLI International, Inc.Class IIChlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Superpotent Drug: Stability failure for assay at 6 months test time-point.
- 2024-11-06FDA-DrugDr. Reddy's Laboratories, Inc.Class IICinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- 2024-11-06FDA-DrugDr. Reddy's Laboratories, Inc.Class IICinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- 2024-11-06FDA-DrugDr. Reddy's Laboratories, Inc.Class IICinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- 2024-10-30FDA-DrugAkron Pharma, Inc.Class IIOneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
CGMP Deviations
- 2024-10-30FDA-DrugC & A NaturisticsClass IIAK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
- 2024-10-30FDA-DrugFresenius Kabi Compounding, LLCClass IIThiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
cGMP violations
- 2024-10-30FDA-DrugFresenius Kabi Compounding, LLCClass IIEPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
cGMP violations
- 2024-10-30FDA-DrugFresenius Kabi Compounding, LLCClass IIOxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
cGMP violations
- 2024-10-30FDA-DrugFresenius Kabi Compounding, LLCClass IINORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
cGMP violations
- 2024-10-30FDA-DrugFresenius Kabi Compounding, LLCClass IINORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
cGMP violations
- 2024-10-30FDA-DrugFresenius Kabi Compounding, LLCClass IIVancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
cGMP violations
- 2024-10-30FDA-DrugFresenius Kabi Compounding, LLCClass IIPhenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
cGMP violations
- 2024-10-30FDA-DrugFresenius Kabi Compounding, LLCClass IIPhenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
cGMP violations
- 2024-10-30FDA-DrugFresenius Kabi Compounding, LLCClass IIPhenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
cGMP violations
- 2024-10-30FDA-DrugFresenius Kabi Compounding, LLCClass IIPhenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
CGMP violations
- 2024-10-23FDA-DrugZhejiang Jingwei Pharmaceutical Co., Ltd.Class IIFirst Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
- 2024-10-23FDA-DrugBionpharma Inc.Class IAtovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
- 2024-10-23FDA-DrugVIONA PHARMACEUTICALS INCClass IIDapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Crystallization
- 2024-10-23FDA-DrugACCORD HEALTHCARE, INC.Class IICisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38
Failed Impurities/Degradation Specifications.
- 2024-10-23FDA-DrugBreckenridge Pharmaceutical, IncClass IIDuloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- 2024-10-16FDA-Drug123HerbalsClass IVail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
- 2024-10-09FDA-DrugAdvanced Accelerator Applications USA, Inc.Class IIPluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
CGMP deviations
- 2024-10-09FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIRyaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27.
Defective Delivery System: The dip tube is clogged causing the spray not to work.
- 2024-10-09FDA-DrugGilead Sciences, Inc.Class IVeklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2
Presence of Particulate Matter: Presence of glass particle.
- 2024-10-09FDA-DrugSupercore Products Group Inc.Class IGold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
- 2024-10-09FDA-DrugSupercore Products Group Inc.Class IHard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
- 2024-10-09FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIICiclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Defective Container: Firm received complaints of broken tube at the seal.
- 2024-10-09FDA-DrugNivagen Pharmaceuticals IncClass IIStop using Nivagen Atorvastatin 40mg tablets
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
- 2024-10-02FDA-DrugAscend Laboratories, LLCClass IIMycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
Failed Dissolution Specifications
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