Class II Recall

Amneal Pharmaceuticals of New York, LLC

Product
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Reason
Failed Dissolution Specifications
Classification
Class II
Status
Terminated
Lot
Lot # HM03221A, Exp. date 12/31/2023
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.