Recall: D-0825-2021

Class II - Potentially Harmful

Class IIClassification

2021-08-27Initiated

TerminatedStatus

Glenmark Pharmaceuticals Inc.,Firm

Product

Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Reason

CGMP Deviations

Distribution

Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.