FDA recall D-1142-2023

Lundbeck LLC · Class III · drug

Product

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

Distribution

Nationwide within the U.S.

Key facts

Status
Completed
Initiation date
2023-08-17
Report date
2023-09-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1142-2023