Glenmark Pharmaceuticals recalls Fulvestrant injection due to lack of sterility assurance. This medication may contain contaminants that could cause infection. Affected products have specific NDC numbers and expiration dates.
Lack of Assurance of Sterility
Glenmark Pharmaceuticals is recalling Fulvestrant injection 250 mg/5 mL (50 mg/mL) pre-filled syringes because they may not be sterile. This could lead to infections if used improperly. Patients with this medication should contact their doctor or pharmacy for guidance.
The medication may not be sterile, meaning it could contain harmful bacteria or other contaminants. If injected, this could cause infections or other health issues. However, the recall is for products that were manufactured with potential sterility issues, not all Fulvestrant products.
Patients prescribed Fulvestrant injection by a doctor who have the recalled product. Those using the medication for breast cancer treatment are most at risk.
Check for the NDC numbers 68462-317-32 and lots 30200014 through 30210031 on the product label. The expiration dates range from April 30, 2022, to February 28, 2023.
Look for the NDC number 68462-317-32 and expiration dates between April 30, 2022, and February 28, 2023.
The recall indicates potential sterility issues, but the medication may still be safe if not contaminated. Consult your doctor or pharmacist for specific advice.
Check the product label for NDC 68462-317-32 and expiration dates from April 30, 2022, to February 28, 2023.
Contact your doctor or pharmacist for guidance on whether to continue using the medication or return it.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0820-2021 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0820-2021 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
