Pro-fluoxetine 10 Mg Capsule; May Exceed The Interim Acceptable Intake Limit For N-nitroso-fluoxetine
PRO-Fluoxetine 10 mg capsules are being recalled because they may contain higher levels of N-nitroso-fluoxetine than permitted. N-nitroso-fluoxetine is an impurity that can form during drug manufacturing. The recall affects PRO-Fluoxetine 10 mg capsules distributed across Canada.
- Product
- PRO-Fluoxetine 10 mg capsule
- Reason
- Product quality
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DRUGS
- Recall date
- 2025-06-30
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DRUGS
Recall details on Nibble Recalls: https://trynibble.app/recalls/5a52e37d-cae3-4c70-bc9a-1b53f6720739