Why it was recalled
Cross contamination with other products
Product description
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Lot numbers, UPCs & expiration codes
Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .
Where it was sold
Nationwide within the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1142-2023
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Aug 17, 2023
- FDA report date
- Sep 6, 2023
- Quantity
- 10,543 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lundbeck LLC
Original FDA data
Every field from FDA enforcement report D-1142-2023, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Completed
- Country
- United States
- Event ID
- 92894
- Address
- 6 Parkway North Blvd Ste 400
- Code information
- Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .
- Postal code
- 60015-2522
- Report date
- Sep 6, 2023
- Product type
- Drugs
- Recall number
- D-1142-2023
- Classification
- Class III
- Recalling firm
- Lundbeck LLC
- Product quantity
- 10,543 cartons
- Reason for recall
- Cross contamination with other products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
- Distribution pattern
- Nationwide within the U.S.
- Recall initiation date
- Aug 17, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 29, 2023