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 # B200076
    • Exp 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 18, 2024 · Data as of Sep 19, 8:07 PM UTC

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