Pms-fluoxetine 10 Mg Capsule; May Exceed The Interim Acceptable Intake Limit For N-nitroso-fluoxetine

PMS-Fluoxetine 10 mg capsules are being recalled in Canada because they may contain higher levels of N-nitroso-fluoxetine than acceptable. N-nitroso-fluoxetine is an impurity that can form during drug manufacturing. This recall affects all PMS-Fluoxetine 10 mg capsules distributed across Canada.

Product
PMS-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/7e3b2851-d9aa-4f9d-8cdf-afaa6764880b