Direct Rx recalls Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
Recalled June 1, 2022 · FDA recall D-0888-2022 · Direct Rx
Hazard
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. · FDA Class II
Units
16 bottles
Sold at
Nationwide to the U.S. market
Description
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Product
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
Manufacturer(s)
Direct Rx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →