FDA-Drug2021-09-29Class II
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
Direct Rx
Hazard
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Sold states
FL only
Affected count
2 bottles
Manufactured in
94 Worldwide Dr, Dawsonville, GA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0829-2021Don't want to check this manually?
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