Glenmark Pharmaceuticals Inc., USA recalls Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-13
Recalled May 4, 2022 · FDA recall D-0793-2022 · Glenmark Pharmaceuticals Inc., USA
Hazard
cGMP deviations · FDA Class II
Units
a) 7,044 bottles; b) 1,014 bottles
Sold at
USA nationwide
Description
cGMP deviations
Product
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →