Sandoz Fesoterodine Fumarate 8 Mg Tablet; Out-of-specification (diester Impurity)
Sandoz is recalling Fesoterodine Fumarate 8 mg tablets across Canada because testing found higher-than-allowed levels of a diester impurity in the product. Fesoterodine is a medication used to treat overactive bladder. This is a Class I recall, indicating a serious quality issue with the distributed product.
- Product
- Sandoz Fesoterodine Fumarate 8 mg tablet
- Reason
- Product quality
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DRUGS
- Recall date
- 2024-05-16
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DRUGS
Recall details on Nibble Recalls: https://trynibble.app/recalls/52442aff-2645-453d-b57a-f641ee45cfce