Class II · Moderate risk Terminated
Zonisamide Capsules USP
Reason CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Zonisamide Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
What was recalled
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 68462-130-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0793-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Zonisamide recalls
See all
Class II · Moderate risk Completed
Zonisamide Capsules
Reason cGMP deviations
Class II · Moderate risk Completed
Zonisamide Capsules USP
Reason cGMP deviations
Class II · Moderate risk Terminated
Zonisamide 100 mg Capsules
Reason CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II · Moderate risk Terminated
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark…
Reason CGMP Deviations
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