Sun Pharmaceutical recalls 12.5mg Zolpidem Extended-Release Tablets due to microbial contamination in manufacturing equipment. Affected lots may pose health risks if used.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sun Pharmaceutical is recalling 12.5mg Zolpidem Tartrate Extended-Release Tablets because microbial contamination was found in the manufacturing equipment. This could lead to health risks if the medication is taken.
Microbial contamination occurred in stagnant water within the manufacturing equipment. This could lead to harmful bacteria entering the medication during production, potentially causing health issues when taken.
People with prescriptions for this medication are affected. Those who have the specific lot number or expiration date mentioned in the recall are most at risk.
Check for the product name 'Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle'. Look for the lot number DNE0893A and expiration date 07/31/2026 on the packaging.
Look for the lot number DNE0893A and expiration date 07/31/2026 on the packaging.
The recall indicates a potential microbial contamination risk, so it is not recommended to use the affected lot.
Check the product details to see if you have the affected lot number DNE0893A. If so, contact Sun Pharmaceutical for further instructions.
The recall record does not specify a replacement process or remedy.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0272-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0272-2024 from Sun Pharmaceutical. 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.
