August 2023 FDA Recall Sabril by Lundbeck Llc
D-1142-2023 - Cross contamination with other products
This Class III drug recall was voluntarily initiated by Lundbeck Llc on August 17, 2023 for the product Sabril. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-1142-2023
Cross contamination with other products
08-17-2023
09-06-2023
10,543 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lundbeck LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the U.S.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Batch or Lot Expiration Information
Lot# : 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .
