Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, N... — FDA record D-1142-2023

Reported completed

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 17, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Reason
Cross contamination with other products
Classification
Class III
Recalling firm
Lundbeck LLC
Quantity
10,543 cartons
Agency-reported status
Completed
Source record identifier
D-1142-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within the U.S.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Sep 6, 2023
Recall initiation date
Aug 17, 2023
Center classification date
Aug 29, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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