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ZONISAMIDE Recall D-0888-2022

Description: Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90

ZONISAMIDE Recall D-0888-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0888-2022
Event ID90215
Active SubstanceZONISAMIDE
Drug RouteORAL
DistributionNationwide to the U.S. market
Quantity16 bottles
Recall ReasonCGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Drug ClassificationClass II
Drug Code Info20220601
Product NDC61919-775
Product NUIN0000175753 N0000008486 M0020790
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 Date20220513
Report Date20220601
Classification Date20220520
Address94 Worldwide Dr
Dawsonville, GA 30534-6828
United States
Recalling FirmDirect Rx
Initial Notification Letter
Unique Ingredient Identifier459384H98V
Drug Application NumberANDA077651
Structured Product Labeling (SPL ID)ca4069e7-85af-56d3-e053-2a95a90a0227
Structured Product Labeling (SPL Set ID)9001965b-dbf6-5504-e053-2a95a90a3c43
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