FDA Drug Class II — Moderate

Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90

Hazard

CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.

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Products

Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 619
Brand
Direct Rx
UPC
Lot: 23JY2124 Exp. 6/30/23

Units Affected

16 bottles

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