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Class II Recall
Zydus Pharmaceuticals (USA) Inc
Product
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
Reason
Failed Impurities/Degradation Specifications
Classification
Class II
Status
Terminated
Lot
Lot # B200076; Exp 31 JAN 2024
Date
2022-08-24
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.