Drug 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
D-0220-2024
Product summary
- Event
- Event 93422
- Status
- Completed
- Classification
- Class I
- Quantity
- 1240 boxes
- Official record key
drug-enforcement:D-0220-2024
Official wording
Reason: Defective Container: powder may leak out of the pouch
Code information: Lot #: NB301030, Exp. Date 03/31/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Defective Container: powder may leak out of the pouch