Recall: D-0793-2022

Class II - Potentially Harmful

Class IIClassification

2022-04-25Initiated

CompletedStatus

Glenmark Pharmaceuticals Inc.,Firm

Product

Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Reason

cGMP deviations

Distribution

USA 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.