FDAFDA · Food and drugs·Recall number D-0829-2021
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
Published September 29, 2021 · Recall initiated: September 14, 2021
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
- FL only
- Lot
- Lot #: 17JU2118 Exp. 5/31/23
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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