Recalls / Class III
Class IIID-1142-2023
Product
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
- Brand name
- Sabril
- Generic name
- Vigabatrin
- Active ingredient
- Vigabatrin
- Route
- Oral
- NDC
- 67386-211
- FDA application
- NDA022006
- Affected lot / code info
- Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .
Why it was recalled
Cross contamination with other products
Recalling firm
- Firm
- Lundbeck LLC
- Manufacturer
- Lundbeck Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6 Parkway North Blvd Ste 400, N/A, Deerfield, Illinois 60015-2522
Distribution
- Quantity
- 10,543 cartons
- Distribution pattern
- Nationwide within the U.S.
Timeline
- Recall initiated
- 2023-08-17
- FDA classified
- 2023-08-29
- Posted by FDA
- 2023-09-06
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1142-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.