Health Products

Sandoz Fesoterodine Fumarate 8 mg tablet; Out of specification (Diester impurity)

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Drugs
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.
Audience: General public, Healthcare, Industry
Recall class: Type II
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Products

BrandProduct NameMarket AuthorizationDosage FormStrengthLot numbers
Sandoz CanadaSandoz Fesoterodine Fumarate 8 mg tabletDIN 02521776Tablet (Extended-Release)Fesoterodine fumarate 8 mg2305011683, 2305012068

Issue

The Diester impurity is out of specification in the affected lots.

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