Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cin...
FDA Recall #D-1142-2023 — Class III — August 17, 2023
Product Description
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Reason for Recall
Cross contamination with other products
Recalling Firm
Lundbeck LLC — Deerfield, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
10,543 cartons
Distribution
Nationwide within the U.S.
Code Information
Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated