Product Safety Recalls

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ZONISAMIDE Recall D-0792-2022

Description: Zonisamide Capsules, USP, 50 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 68462-129-01

ZONISAMIDE Recall D-0792-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0792-2022
Event ID90029
Original Package?1
Active SubstanceZONISAMIDE
Drug RouteORAL
DistributionUSA nationwide
Quantity12,003 bottles
Recall ReasoncGMP deviations
Drug ClassificationClass II
Drug Code Info20220504
Product NDC68462-128 68462-129 68462-130
Product NUIN0000175753 N0000008486 M0020790
Drug UPC0368462130018 0368462128015 0368462129012
Pharma Class (PE)Decreased Central Nervous System Disorganized Electrical Activity [PE]
Pharma Class (EPC)Anti-epileptic Agent [EPC]
Pharma Class (CS)Sulfonamides [CS]
Recall Initiation Date20220425
Report Date20220504
Classification Date20220427
Address750 Corporate Dr
Mahwah, NJ 07430-2009
United States
Recalling FirmGlenmark Pharmaceuticals Inc., USA
Initial Notification Letter
Unique Ingredient Identifier459384H98V
Drug Application NumberANDA077651
Structured Product Labeling (SPL ID)5c503c30-821e-410a-abf7-bd15bb358c11
Structured Product Labeling (SPL Set ID)fe15e56e-8b86-4a65-825c-31d37dd81612
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