Reported Sep 29, 2021 · Terminated

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx…

Glenmark Pharmaceuticals Inc., USA

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: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009

Is this the product you have?

  • Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32
Lot codes and dates
  • Lots
    • 30200014 Exp. 04/30/2022
    • 30200015 Exp. 05/31/2022
    • 30200015 Exp. 05/31/2022
    • 30200016 Exp. 05/31/2022
    • 30200036 Exp. 09/30/2022
    • 30200038 Exp. 09/30/2022
    • 30200039 Exp. 09/30/2022
    • 30200040 Exp. 09/30/2022
    • 30210001 Exp. 12/31/2022
    • 30210002 Exp. 12/31/2022
    • 30210003 Exp. 01/31/2023
    • 30210004 Exp. 01/31/2023
    • 30210005 Exp. 01/31/2023
    • 30210006 Exp. 01/31/2023
    • 30210014 Exp. 02/28/2023
    • 30210022 Exp. 02/28/2023
    • 30210028 Exp. 02/28/2023
    • 30210029 Exp. 02/28/2023
    • 30210030 Exp. 02/28/2023
    • 30210031 Exp. 02/28/2023
Amount recalled
28658 cartons

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 4, 2023 · Data as of Sep 19, 5:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.