FDAFDA · Food and drugs·Recall number D-0793-2022
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Published May 4, 2022 · Recall initiated: April 25, 2022
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ZONISAMIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- USA nationwide
- UPC
- 0368462130018
- Lot
- a) Lot #: 29200053, Exp 4/30/2023; b) Lot #: 29200054, Exp 4/30/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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