Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01
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.
Reason CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Reason cGMP deviations
Reason cGMP deviations
Reason CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Reason CGMP Deviations
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