Drug recall D-0826-2021
Product
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05
Reason for recall
CGMP Deviations
Lots and codes
Lots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 29200031 Exp. 05/31/2023; 29200032 Exp. 05/31/2023; 29200033 Exp. 06/30/2023; 29200037 Exp. 06/30/2023; 29200038 Exp. 06/30/2023; 29200039 Exp. 07/31/2023; 29200041 Exp. 07/31/2023; 29200042 Exp. 07/31/2023; 29200048 Exp. 08/31/2023; 29200049 Exp. 08/31/2023; 29200050 Exp. 08/31/2023; 29200072 Exp. 11/30/2023; 29200073 Exp. 11/30/2023; 29200074 Exp. 11/30/2023; 29200075 Exp. 11/30/2023; 29200076 Exp. 11/30/2023; b) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- a) 216,454 bottles; b) 2166 bottles
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 27, 2021
- Terminated
- October 4, 2023
Related products
- Zonisamide – drug information
- NDC 68462-130 Zonisamide · Zonisamide 100 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-129 Zonisamide · Zonisamide 50 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-128 Zonisamide · Zonisamide 25 mg/1 · Glenmark Pharmaceuticals Inc., USA