Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30

FDA recall notice · announced September 29, 2021 · Direct Rx

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30

Reason for recall

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

Notes

Distribution: FL only
Lot/code information: Lot #: 17JU2118 Exp. 5/31/23
Quantity: 2 bottles
Status: Terminated
Products in this recall event:
- Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30 (D-0829-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.