FDA-Drug2022-06-01Class II
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
Direct Rx
Hazard
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Sold states
Nationwide to the U.S. market
Affected count
16 bottles
Manufactured in
94 Worldwide Dr, Dawsonville, GA, United States
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 61919-775-90
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0888-2022Don't want to check this manually?
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