FDAFDA · Food and drugs·Recall number D-0888-2022
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
Published June 1, 2022 · Recall initiated: May 13, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Direct Rx
- Distributor
- Nationwide to the U.S. market
- Lot
- Lot: 23JY2124 Exp. 6/30/23
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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