Recall: D-1351-2022

Class II - Potentially Harmful

Class IIClassification

2022-07-15Initiated

TerminatedStatus

Zydus Pharmaceuticals (USA) InFirm

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

Distribution

Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.