Glenmark Pharmaceuticals recalls 25mg Zonisamide Capsules due to cGMP deviations. This affects 100-count bottles with specific lot numbers. Consumers should contact the manufacturer for details.
cGMP deviations
Glenmark Pharmaceuticals is recalling 25mg Zonisamide Capsules in 100-count bottles due to manufacturing quality control issues. This recall does not involve immediate safety risks but requires consumers to check their product details and contact the company for further instructions.
The recall is due to cGMP (current Good Manufacturing Practices) deviations, which means the product was made under quality control standards that did not meet regulatory requirements. This could potentially affect the product's safety and effectiveness, but the recall does not indicate an immediate risk of injury or serious harm.
People who have the specific 25mg Zonisamide Capsules in 100-count bottles with lot number 29200052 (expiring April 30, 2023) are affected. Prescriptions for this medication are typically for medical conditions requiring careful management.
Check for the product name 'Zonisamide Capsules USP, 25 mg', 100-count bottles, and lot number 29200052 (expiring April 30, 2023). The product is prescription-only and manufactured by Glenmark Pharmaceuticals.
Look for the lot number 29200052 on the bottle label to confirm if it is affected.
The recall is due to manufacturing quality control issues, but the product does not pose an immediate safety risk. Consumers should check their product details and contact the manufacturer for further instructions.
Contact Glenmark Pharmaceuticals directly for specific instructions on how to handle the product. The recall does not require immediate action beyond checking the product details.
The recall is based on manufacturing quality control issues, not an immediate risk of injury or serious harm. The product is safe to use as long as it is checked for the specific lot number.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0791-2022 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0791-2022 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.
