Recalls / Class I
Class ID-0220-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Vigabatrin
- Generic name
- Vigabatrin
- Active ingredient
- Vigabatrin
- Route
- Oral
- NDC
- 69097-964
- FDA application
- ANDA211592
- Affected lot / code info
- Lot #: NB301030, Exp. Date 03/31/2025
Why it was recalled
Defective Container: powder may leak out of the pouch
Recalling firm
- Firm
- InvaGen Pharmaceuticals, Inc.
- Manufacturer
- Cipla USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 550 S Research Pl, Central Islip, New York 11722-4415
Distribution
- Quantity
- 1240 boxes
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-11-17
- FDA classified
- 2024-01-08
- Posted by FDA
- 2024-01-17
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0220-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.