Mylan recalls 40mg esomeprazole capsules with impurities detected. These capsules, sold with specific lot numbers and expiration dates, may pose health risks if used. Consumers should check their product details and contact Mylan for guidance.
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Mylan is recalling certain esomeprazole capsules due to impurities detected in lab tests. This could lead to health risks if the capsules are taken as directed. Affected products have specific lot numbers and expiration dates.
The lab tests found impurities in the capsules that could be harmful when taken. These impurities were detected at a specific temperature and time, indicating a potential issue with the manufacturing process. The capsules are meant for prescription use, so the risk is only for people who have been prescribed them.
People who have the specific lot numbers listed (3110437, 3111409, 3110785, 3112173) of esomeprazole capsules with expiration dates up to November 30, 2022. Those using prescription-strength esomeprazole for acid reflux or ulcers are most at risk.
Check the product label for the lot numbers 3110437, 3111409, 3110785, or 3112173. The capsules are packaged in unit dose blister cards of 6 per 10 cards per carton and expire by July 31, 2022 or November 30, 2022.
Look for the lot numbers 3110437, 3111409, 3110785, or 3112173 on the capsule packaging.
The recall record states that impurities were detected in lab tests, but it does not specify if the capsules are safe to take. Consumers should check their product details and contact Mylan for guidance.
The recall record does not provide a specific remedy, so the official notice does not say what to do. Check the product details and contact Mylan for further instructions.
Check the product label for the lot numbers 3110437, 3111409, 3110785, or 3112173. The capsules are packaged in unit dose blister cards of 6 per 10 cards per carton and expire by July 31, 2022 or November 30, 2022.
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0861-2022 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0861-2022 from Mylan. 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.
