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 for recall: Failed Impurities/Degradation Specifications
Recall initiated: 20220715
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated