D-0826-2021 Class II Terminated
FDA drug recall D-0826-2021 was initiated by Glenmark Pharmaceuticals Inc., USA on August 27, 2021 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated October 4, 2023). Affected quantity: a) 216,454 bottles; b) 2166 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 29, 2021
- Initiation Date
- August 27, 2021
- Termination Date
- October 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 216,454 bottles; b) 2166 bottles
Product Description
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
Distribution Pattern
Nationwide.
Code Information
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