FDA Recall D-0220-2024
InvaGen Pharmaceuticals, Inc. · Central Islip, NY
Class I — life-threatening Completed 909 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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 for recall
Defective Container: powder may leak out of the pouch
Recall record
- Recall number
D-0220-2024- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2023-11-17
- Classified by FDA Center
- 2024-01-08
- FDA published
- 2024-01-17
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- Firm location
- Central Islip, NY
Drug identification
- Brand name(s)
- VIGABATRIN
- Generic name(s)
- VIGABATRIN
- Manufacturer(s)
- Cipla USA, Inc.
- NDC(s)
69097-964- Route(s)
- ORAL