Product Safety Recalls

Product Recall Tracker

VIGABATRIN Recall D-1142-2023

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

VIGABATRIN Recall D-1142-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1142-2023
Event ID92894
Original Package?1
Active SubstanceVIGABATRIN
Drug RouteORAL
DistributionNationwide within the U.S.
Quantity10,543 cartons
Recall ReasonCross contamination with other products
Drug ClassificationClass III
Drug Code Info20230906
Product NDC67386-211
Product NUIN0000175753
Pharma Class (EPC)Anti-epileptic Agent [EPC]
Recall Initiation Date20230817
Report Date20230906
Classification Date20230829
Address6 Parkway North Blvd Ste 400
Deerfield, IL 60015-2522
United States
Recalling FirmLundbeck LLC
Initial Notification Letter
Unique Ingredient IdentifierGR120KRT6K
Drug Application NumberNDA022006
Structured Product Labeling (SPL ID)bdc6160d-f41f-4539-b68c-81de0735b6fc
Structured Product Labeling (SPL Set ID)a88ac1b4-e2c9-45c0-b321-4785902172e3
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.