Sandoz Fesoterodine Fumarate: The Diester Impurity Is Out Of Specification In The Affected Lot(s)

Sandoz is recalling certain lots of Fesoterodine Fumarate because they contain a higher-than-acceptable level of a chemical impurity called diester. Fesoterodine Fumarate is a medication used to treat overactive bladder. This recall applies to the affected lots distributed across Canada.

Product
SANDOZ FESOTERODINE FUMARATE
Reason
Product safety
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DRUGS
Recall date
2024-12-09
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DRUGS

Recall details on Nibble Recalls: https://trynibble.app/recalls/4ff9d972-8efc-4e3c-a6c7-bfd714699496