FDA Drug recall D-0220-2024
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsid…
- FDA Drug
- Class I
- completed
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class I recall of Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsid… by Invagen Pharmaceuticals, citing defective Container: powder may leak out of the pouch.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0220-2024 |
| Classification | Class I |
| Status | completed |
| Initiated | 2023-11-17 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Invagen Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Defective Container: powder may leak out of the pouch
Identifiers
| ndc | 69097-964-53 |
|---|---|
| code_info | Lot #: NB301030, Exp. Date 03/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0220-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.