US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 1, 2015 (11 years ago)

Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5…

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

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

What was recalled

Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Recalling firm
American Health Packaging
NDC code
68084-008-11
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1230-2015

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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