US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 14, 2021 (5 years ago)

Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.

What was recalled

Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30

Recalling firm
Direct Rx
NDC code
61919-0775-30
Origin
GA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0829-2021

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.

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