VIGABATRIN Recall D-0220-2024
Description: Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53
VIGABATRIN Recall D-0220-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0220-2024 |
| Event ID | 93422 |
| Brand | VIGABATRIN |
| Generic Name | VIGABATRIN |
| Manufacturer | VIGABATRIN |
| Original Package? | 1 |
| Active Substance | VIGABATRIN |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | 1240 boxes |
| Recall Reason | Defective Container: powder may leak out of the pouch |
| Drug Classification | Class I |
| Drug Code Info | 20240117 |
| Product NDC | 69097-964 |
| Product NUI | N0000175753 |
| Pharma Class (EPC) | Anti-epileptic Agent [EPC] |
| Recall Initiation Date | 20231117 |
| Report Date | 20240117 |
| Classification Date | 20240108 |
| Address | 550 S Research Pl Central Islip, NY 11722-4415 United States |
| Recalling Firm | InvaGen Pharmaceuticals, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | GR120KRT6K |
| Drug Application Number | ANDA211592 |
| Structured Product Labeling (SPL ID) | 4cdad60f-7614-47cb-8594-3c0257e55c28 |
| Structured Product Labeling (SPL Set ID) | 823cc915-0350-4780-85ed-cd1c338e429d |
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