Reported Sep 29, 2021 · Terminated
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110…
Glenmark Pharmaceuticals Inc., USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- Zonisamide Capsules
- USP 100 mg Rx Only Manufactured byGlenmark Pharmaceuticals Inc., USA Monroe
- NC 28110 Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05
- Lot codes and dates
- Lots
a) 29200014 Exp. 02/28/202329200015 Exp. 03/31/202329200016 Exp. 03/31/202329200030 Exp. 05/31/202329200031 Exp. 05/31/202329200032 Exp. 05/31/202329200033 Exp. 06/30/202329200037 Exp. 06/30/202329200038 Exp. 06/30/202329200039 Exp. 07/31/202329200041 Exp. 07/31/202329200042 Exp. 07/31/202329200048 Exp. 08/31/202329200049 Exp. 08/31/202329200050 Exp. 08/31/202329200072 Exp. 11/30/202329200073 Exp. 11/30/202329200074 Exp. 11/30/202329200075 Exp. 11/30/202329200076 Exp. 11/30/2023b) 29200014 Exp. 02/28/202329200015 Exp. 03/31/202329200016 Exp. 03/31/2023
- Lots
- Amount recalled
- a) 216,454 bottles; b) 2166 bottles
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations
This product could cause temporary or reversible health problems — stop using it.
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