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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0888-2022 |
| Event ID | 90215 |
| Brand | ZONISAMIDE |
| Generic Name | ZONISAMIDE |
| Manufacturer | ZONISAMIDE |
| Active Substance | ZONISAMIDE |
| Drug Route | ORAL |
| Distribution | Nationwide to the U.S. market |
| Quantity | 16 bottles |
| Recall Reason | CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. |
| Drug Classification | Class II |
| Drug Code Info | 20220601 |
| Product NDC | 61919-775 |
| Product NUI | N0000175753 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 Date | 20220513 |
| Report Date | 20220601 |
| Classification Date | 20220520 |
| Address | 94 Worldwide Dr Dawsonville, GA 30534-6828 United States |
| Recalling Firm | Direct Rx |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 459384H98V |
| Drug Application Number | ANDA077651 |
| 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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