Sandoz Fesoterodine Fumarate 8 mg tablet; Out of specification (Diester impurity)
Brand(s)
Last updated
Summary
Product
Sandoz Fesoterodine Fumarate 8 mg tablet
Issue
Health products - Product quality
What to do
Consult your health care professional if you have any health concerns.
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot numbers |
|---|---|---|---|---|---|
Sandoz Canada |
Sandoz Fesoterodine Fumarate 8 mg tablet |
DIN 02521776 |
Tablet (Extended-Release) |
Fesoterodine fumarate 8 mg |
2305011683, 2305012068 |
Issue
The Diester impurity is out of specification in the affected lots.
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Related recalls and alerts
Additional information
Background
Depth of recall: Retailers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Sandoz Canada Incorporated
110 Rue de Lauzon,
Boucherville, QC, Canada J4B 1E6
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-77155
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