Reported Aug 24, 2022 · Terminated
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India,…
Zydus Pharmaceuticals (USA) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India
- Manufactured byCadila Healthcare Limited, Ahmadabad, India
- Distributed byZydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8
- Lot codes and dates
Lot # B200076Exp 31 JAN 2024
- Amount recalled
- 1116 boxes
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications
This product could cause temporary or reversible health problems — stop using it.
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