FDA-Drug2022-05-04Class II
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
Glenmark Pharmaceuticals Inc., USA
Hazard
cGMP deviations
Sold states
USA nationwide
Affected count
a) 7,044 bottles; b) 1,014 bottles
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0793-2022Don't want to check this manually?
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