Pro-fluoxetine: Affected Lots Exceed The Interim Acceptable Intake Limit For N-nitroso-fluoxetine.
Pro-Fluoxetine tablets distributed across Canada are being recalled because certain batches contain higher-than-acceptable levels of N-nitroso-fluoxetine, a substance that can form during drug manufacturing. This is a Class I recall, meaning the product poses a potential health risk. The recall affects all Pro-Fluoxetine products distributed in Canada.
- Product
- PRO-FLUOXETINE
- Reason
- Product quality
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DRUGS
- Recall date
- 2025-04-28
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DRUGS
Recall details on Nibble Recalls: https://trynibble.app/recalls/7062cffd-8b80-47fd-a3a8-ea7b7f065215