VIGABATRIN Recall D-1142-2023
Description: Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
VIGABATRIN Recall D-1142-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1142-2023 |
| Event ID | 92894 |
| Brand | SABRIL |
| Generic Name | VIGABATRIN |
| Manufacturer | VIGABATRIN |
| Original Package? | 1 |
| Active Substance | VIGABATRIN |
| Drug Route | ORAL |
| Distribution | Nationwide within the U.S. |
| Quantity | 10,543 cartons |
| Recall Reason | Cross contamination with other products |
| Drug Classification | Class III |
| Drug Code Info | 20230906 |
| Product NDC | 67386-211 |
| Product NUI | N0000175753 |
| Pharma Class (EPC) | Anti-epileptic Agent [EPC] |
| Recall Initiation Date | 20230817 |
| Report Date | 20230906 |
| Classification Date | 20230829 |
| Address | 6 Parkway North Blvd Ste 400 Deerfield, IL 60015-2522 United States |
| Recalling Firm | Lundbeck LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | GR120KRT6K |
| Drug Application Number | NDA022006 |
| Structured Product Labeling (SPL ID) | bdc6160d-f41f-4539-b68c-81de0735b6fc |
| Structured Product Labeling (SPL Set ID) | a88ac1b4-e2c9-45c0-b321-4785902172e3 |
| Similar To |