Sandoz Fesoterodine Fumarate 8 Mg Tablet; Out Of Specification (diester Impurity)
Sandoz is recalling Fesoterodine Fumarate 8 mg tablets distributed across Canada because the product contains higher-than-allowed levels of a diester impurity, which is a quality issue. Fesoterodine is a medication used to treat overactive bladder. This is a Class I recall, the most serious classification.
- Product
- Sandoz Fesoterodine Fumarate 8 mg tablet
- Reason
- Product quality
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DRUGS
- Recall date
- 2025-03-21
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DRUGS
Recall details on Nibble Recalls: https://trynibble.app/recalls/17f6fa56-4251-4992-9cf1-3b37e159dd4f