Sun Pharmaceutical Industries recalls 180mg fexofenadine tablets due to microbial contamination in manufacturing equipment. Affected lots from India with specific NDC numbers and expiration dates. Consumers should check their product details and contact the manufacturer for guidance.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sun Pharmaceutical Industries is recalling 180mg fexofenadine hydrochloride tablets that may have microbial contamination from manufacturing equipment. This recall affects specific lots produced in India with certain NDC numbers and expiration dates. The contamination could pose a health risk if the tablets are taken without proper cleaning.
Microbial contamination was found in stagnant water within the manufacturing equipment's ducts. This could lead to potential contamination of the tablets during production, though the exact risk level is not specified in the recall notice.
People who purchased the recalled fexofenadine tablets from specific distributors like Ohm Laboratories or CVS Pharmacy in the US. Those with the listed NDC numbers and expiration dates are most at risk.
Check for the NDC numbers 51660-998-30, 51316-800-45, or 51660-998-55 on the bottle. The tablets were made in India with specific expiration dates listed in the recall notice.
Look for the NDC numbers and expiration dates listed in the recall notice to confirm if your tablets are affected.
The recall states there was microbial contamination in manufacturing equipment, but the exact risk level is not specified. Consumers should check if their product is affected and follow the manufacturer's guidance.
Check the NDC numbers on the bottle: 51660-998-30, 51316-800-45, or 51660-998-55 with specific expiration dates listed in the recall notice.
The recall does not specify a remedy, so contact Sun Pharmaceutical Industries directly for further instructions.
We’ve drafted a message you can send Sun Pharmaceutical Industries to request your refund or repair — edit it as you like.
Subject: Recall D-0273-2024 — Sun Pharmaceutical Industries Sun Pharmaceutical Industries Hello, I own a Sun Pharmaceutical Industries that is covered by recall D-0273-2024 from Sun Pharmaceutical Industries. 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.
