Glenmark Pharmaceuticals recalls 50mg Zonisamide Capsules due to CGMP deviations. Affected lots expire May 2022. No remedy stated in official notice.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 50mg Zonisamide Capsules (NDC 68462-129-01) because of manufacturing quality control issues. This recall affects patients prescribed this medication who may have received the recalled lots. The recall does not include a specific remedy or action for consumers.
CGMP deviations refer to manufacturing quality control failures that could affect the safety and effectiveness of the medication. These deviations may lead to inconsistent drug quality, but the specific risk to patients is not clearly described in the recall notice.
Patients prescribed Zonisamide Capsules by a doctor who received the recalled lots (expiring May 2022) are affected. People using this medication for conditions like seizures or nerve pain are most at risk.
Check if your Zonisamide Capsules are labeled '50 mg 100 Capsules Rx Only' with NDC 68462-129-01. The product was manufactured in lots 29190043, 29190044, or 29190045 and expires May 31, 2022.
Look for the NDC code 68462-129-01 and expiration date of May 31, 2022 on the capsule packaging.
The recall notice does not specify a remedy, so there is no instruction to stop using the product.
Check for the NDC code 68462-129-01 and expiration date of May 31, 2022 on the packaging.
The official recall notice does not provide any action steps for consumers.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0825-2021 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0825-2021 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.
