Glenmark Pharmaceuticals recalls 100mg Zonisamide Capsules due to cGMP deviations in manufacturing. Affected lots expire 4/30/2023. Consumers should contact the manufacturer for details.
cGMP deviations
Glenmark Pharmaceuticals is recalling 100mg Zonisamide Capsules that were manufactured with cGMP deviations. This recall affects specific bottle sizes and lot numbers that expire by April 30, 2023. The issue means the product may not meet quality standards, but the recall does not indicate immediate safety risks to consumers.
The product was made with cGMP deviations, which means it may not meet the quality standards required for safe drug production. This could lead to inconsistent drug strength or impurities, but the recall does not indicate an immediate safety risk to consumers.
People who have the specific 100-count or 500-count bottles with lot numbers 29200053 or 29200054 are affected. Prescriptions for these capsules are at risk of being manufactured with quality issues.
Check for 100-count bottles labeled NDC 68462-130-01 or 500-count bottles labeled NDC 68462-130-05 with lot numbers 29200053 or 29200054. These products expire by April 30, 2023.
Look for the specific bottle sizes and lot numbers mentioned in the recall to confirm if your product is affected.
The product was manufactured with cGMP deviations, which means it may not meet quality standards for safe drug production.
Check for 100-count bottles labeled NDC 68462-130-01 or 500-count bottles labeled NDC 68462-130-05 with lot numbers 29200053 or 29200054.
The recall does not specify a remedy, so contact Glenmark Pharmaceuticals for further instructions.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0793-2022 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0793-2022 from Glenmark. 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.
