ZONISAMIDE Recall D-0791-2022
Description: 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
ZONISAMIDE Recall D-0791-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0791-2022 |
| Event ID | 90029 |
| Brand | ZONISAMIDE |
| Generic Name | ZONISAMIDE |
| Manufacturer | ZONISAMIDE |
| Original Package? | 1 |
| Active Substance | ZONISAMIDE |
| Drug Route | ORAL |
| Distribution | USA nationwide |
| Quantity | 11,136 bottles |
| Recall Reason | cGMP deviations |
| Drug Classification | Class II |
| Drug Code Info | 20220504 |
| Product NDC | 68462-128 68462-129 68462-130 |
| Product NUI | N0000175753 N0000008486 M0020790 |
| Drug UPC | 0368462130018 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 Date | 20220425 |
| Report Date | 20220504 |
| Classification Date | 20220427 |
| Address | 750 Corporate Dr Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 459384H98V |
| Drug Application Number | ANDA077651 |
| 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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