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: 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.
Other Zonisamide recalls
See all
Class II · Moderate risk Completed
Zonisamide Capsules
Reason cGMP deviations
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.
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