Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0888-2022
Event ID90215
BrandZONISAMIDE
Generic NameZONISAMIDE
ManufacturerZONISAMIDE
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
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.