Brand
Amneal Pharmaceuticals of New York, LLC
6 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Amneal Pharmaceuticals of New York, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-05-08FDA-DrugClass IIMethylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Failed Dissolution Specifications
- 2024-04-24FDA-DrugClass IVancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Superpotent Drug: Due to overfilling of drug powder
- 2024-04-03FDA-DrugClass IIDivalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
Failed dissolution specifications
- 2024-02-28FDA-DrugClass IIOseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
Failed Impurities/Degradation Specifications: Out-of-specification test results.
- 2024-02-14FDA-DrugClass IIPhenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
- 2023-11-15FDA-DrugClass IIExtended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Failed Dissolution Specifications
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