Sun Pharmaceutical recalls 1000mg Niacin 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 1000mg Niacin Extended-Release Tablets because microbial contamination was found in the manufacturing equipment. This could pose a health risk if the tablets are taken.
Microbial contamination was reported in stagnant water within the manufacturing equipment's duct. This could lead to harmful bacteria entering the tablets during production, potentially causing health issues if consumed.
People who have the specific lot number DNE0788A of Sun Pharmaceutical's 1000mg Niacin Extended-Release Tablets are affected. Prescriptions for this medication are at risk of contamination.
Check for the lot number DNE0788A on the packaging of the 1000mg Niacin Extended-Release Tablets. The product was distributed by Sun Pharmaceutical Industries, Inc. in the US.
Look for the lot number DNE0788A on the packaging of the recalled Niacin Extended-Release Tablets.
The recall record states microbial contamination was found in the manufacturing equipment, but does not specify if the product is safe to use.
The recall record does not provide specific action steps for affected individuals.
Check the lot number DNE0788A on the packaging of the 1000mg Niacin Extended-Release Tablets.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0269-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0269-2024 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.