FDAClass IIISeptember 6, 2023

Sabril recall: Contamination

Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65

Why was Sabril recalled?

Cross contamination with other products

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .

Product
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Recalling firm
Lundbeck LLC
Quantity
10,543 cartons
Distribution
Nationwide within the U.S.
Recall date
September 6, 2023
Classification
Class III
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls