Glenmark Pharmaceuticals recalls 100mg Zonisamide Capsules due to CGMP deviations. Affected lots expire through July 2023. Consumers should check NDC numbers and expiration dates for affected products.
CGMP Deviations
Glenmark Pharmaceuticals is recalling Zonisamide Capsules 100mg (Rx only) because of manufacturing quality control issues. This recall affects specific lots with expiration dates through July 2023. The issue could lead to potential product safety concerns if the capsules were improperly manufactured.
CGMP deviations refer to manufacturing quality control issues that could affect the safety and effectiveness of the medication. These deviations might result in the capsules not meeting the required standards for quality, potentially leading to unsafe or ineffective treatment.
People who have the specific 100mg Zonisamide Capsules with NDC numbers 68462-130-01 or 68462-130-05 and expiration dates through July 2023 are affected. Patients using prescription medication for seizures or other conditions may be at risk if they have these specific lots.
Check the NDC number on the product label: 68462-130-01 for 100 capsules or 68462-130-05 for 500 capsules. Also look for the expiration date on the packaging, which ranges from February 2023 to November 2023 for the affected lots.
Look for the NDC number 68462-130-01 (100 capsules) or 68462-130-05 (500 capsules) and expiration dates from February 2023 to November 2023.
The recall is due to CGMP deviations, which are manufacturing quality control issues that could affect the safety and effectiveness of the medication.
Check the NDC number and expiration date on your product. If it matches the affected lots, contact Glenmark Pharmaceuticals for further instructions.
The recall is for potential safety concerns due to manufacturing quality control issues, but no specific injury risks have been reported.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0826-2021 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0826-2021 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.
