Glenmark Pharmaceuticals recalls 550mg naproxen tablets due to CGMP deviations. Affected lots expire through February 2022. Consumers should contact for details.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 550mg naproxen sodium tablets that were manufactured with CGMP deviations. This recall affects specific lots of tablets that expire through February 2022. The hazard means these tablets may not meet quality standards, though serious injury risks aren't specified.
CGMP deviations refer to quality control issues in manufacturing. These tablets may not meet the required standards for safety and effectiveness. However, the recall does not specify that these tablets could cause serious injury or death.
People who have the specific lots of 550mg naproxen tablets listed in the recall. Those with prescription-only use are most at risk.
Check for the product name 'Naproxen Sodium Tablets, USP 550 mg Rx Only' with the specific lot numbers listed in the recall. The tablets were manufactured by Glenmark Pharmaceuticals Inc., USA.
Identify the lot numbers and expiration dates listed in the recall to confirm if your tablets are affected.
The recall states there were CGMP deviations, but does not specify that these tablets could cause serious injury or death. They may not meet quality standards.
Check the lot numbers and expiration dates listed in the recall: 29190082-29200013 with expiration dates through February 2022.
The recall does not specify a remedy, so contact Glenmark Pharmaceuticals for details on what to do with affected tablets.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0822-2021 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0822-2021 from Glenmark Pharmaceuticals. 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.
