← FDA ENFORCEMENT
D-1142-2023Class III

Lundbeck LLC

Recalling firm
Lundbeck LLC
Product type
Drug
Status
Completed
Report date
2023-09-06
Distribution
Nationwide within the U.S.
Firm state
IL
Product quantity
10,543 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.