MedicineWatch US
Class II Recall

Amneal Pharmaceuticals of New York, LLC

Product
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Reason
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Classification
Class II
Status
Terminated
Lot
Lot # HL00721A, Exp. 12/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Amneal Pharmaceuticals of New York, LLC — Class II Recall | MedicineWatch US