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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