Zydus Pharmaceuticals recalls Fulvestrant injection due to failed impurities and degradation specifications. This prescription drug, sold in single-dose prefilled syringes, may pose health risks if used improperly.
Failed Impurities/Degradation Specifications
Zydus Pharmaceuticals is recalling Fulvestrant injection 250mg/5mL (50 mg/mL) products that contain two single-dose prefilled syringes. The recall is due to potential impurities and degradation in the drug, which could cause health risks if used.
The product failed impurities and degradation specifications, meaning the drug may contain harmful substances or break down in a way that could cause health issues. This is a prescription-only medication, so it's used under medical supervision.
Prescription patients who have received this specific Fulvestrant injection product are affected. Those with a prescription for this medication and the listed lot number are most at risk.
Check for the product name 'Fulvestrant Injection 250mg/5mL (50 mg/mL)' with two single-dose prefilled syringes. The lot number B200076 and expiration date of January 31, 2024, are specific identifiers for this recall.
Look for the lot number B200076 and expiration date of January 31, 2024 on the product label.
The official recall notice states that the product failed impurities and degradation specifications, so it may pose health risks. The manufacturer has not provided a specific remedy, so it's recommended to check the recall details.
The recall record does not specify a remedy, so the official notice does not state what action to take. Check the product details and contact your healthcare provider for guidance.
Check for the lot number B200076 and expiration date of January 31, 2024 on the product label. The product is manufactured by Cadila Healthcare Limited in India and distributed by Zydus Pharmaceuticals (USA) Inc.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1351-2022 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-1351-2022 from Zydus Pharmaceuticals. 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.
