Sun Pharmaceutical recalls 6.25mg 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 6.25mg Zolpidem Extended-Release Tablets because manufacturing equipment had microbial contamination. 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, potentially causing health issues if taken.
Prescription users of Zolpidem 6.25mg tablets in the US. People with specific medical conditions may be at higher risk due to the medication's effects.
Check for the NDC code 47335-307-88 on the bottle. The lot number DNE0892A was produced and expires July 31, 2026.
Look for the NDC code 47335-307-88 and lot number DNE0892A on the bottle.
The recall does not specify if the product is safe to use. The manufacturer reports microbial contamination in manufacturing equipment, but no specific safety advice is given.
The recall record does not provide a remedy or specific action steps for affected products.
Check the NDC code 47335-307-88 and lot number DNE0892A on the bottle. Products with these identifiers are affected.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0271-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0271-2024 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.
