Glenmark Pharmaceuticals recalls 2.5mg Frov: CGMP deviations in manufacturing. Affected tablets may have quality issues. Stop using and contact for details.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 2.5mg Frovatriptan Succinate Tablets in 9-count bottles due to manufacturing quality control deviations. This recall affects prescription-only tablets made in India and distributed in the US. The issue could lead to potential quality problems with the medication.
CGMP deviations refer to failures in the manufacturing process that could affect the safety and quality of the medication. This means the tablets might not meet the required standards for effectiveness and safety.
Prescription holders of the 2.5mg Frovatriptan Succinate Tablets 9-count bottles with NDC 68462-694-97 and lot number 17231352 are affected. Patients using these specific tablets are at risk of potential quality issues.
Check for the 9-count bottle labeled 'Frovatriptan Succinate Tablets 2.5mg', Rx Only. Look for NDC code 68462-694-97 and lot number 17231352 on the packaging.
Verify the NDC code 68462-694-97 and lot number 17231352 on the packaging.
The recall is due to CGMP deviations in the manufacturing process, which could affect the medication's quality and safety.
The official recall notice does not specify a remedy or action steps for affected products.
The recall notice does not describe a specific hazard that could cause injury or serious health issues.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0322-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0322-2025 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.
