Glenmark Pharmaceuticals Inc., USA: Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mah

Is my product affected?

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

• Brand ZONISAMIDE

Check against the official notice below — it lists the full affected range.

What happened

Glenmark Pharmaceuticals Inc., USA is recalling Zonisamide Capsules USP 100 mg distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 216,454 bottles across 20 different lots with expiration dates ranging from February 2023 through November 2023, and an additional 2,166 bottles from three of those same lots.

The source document does not specify a remedy or what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP Deviations

Details from the source

Reason for recall: CGMP Deviations Distribution: Nationwide. Quantity: a) 216,454 bottles; b) 2166 bottles Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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