Direct Rx recalls Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glen
Recalled September 29, 2021 · FDA recall D-0829-2021 · Direct Rx
Hazard
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. · FDA Class II
Units
2 bottles
Sold at
FL only
Description
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
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
Manufacturer(s)
Direct Rx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →