Drug recall D-1351-2022

Class II Terminated reported Aug 24, 2022

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

Lots and codes

Lot # B200076; Exp 31 JAN 2024

Recall details

Recalling firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Quantity
1116 boxes
Distribution
Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
July 15, 2022
Terminated
June 18, 2024

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