Glenmark Pharmaceuticals Inc., USA recalls Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured
Recalled September 29, 2021 · FDA recall D-0826-2021 · Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations · FDA Class II
Units
a) 216,454 bottles; b) 2166 bottles
Sold at
Nationwide.
Description
CGMP Deviations
Product
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →