FDA-Drug2022-05-04Class II
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01
Hazard
cGMP deviations
Sold states
USA nationwide
Affected count
11,136 bottles
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0791-2022More Glenmark Pharmaceuticals Inc., USA recalls
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