Pms-fluoxetine: Affected Lots Exceed The Interim Acceptable Intake Limit For N-nitroso-fluoxetine.

Recall Summary PMS-FLUOXETINE tablets are being recalled across Canada because certain batches contain higher-than-acceptable levels of N-nitroso-fluoxetine, a potentially harmful impurity. This is a Class I recall, meaning the product poses a serious health risk. The recall affects all PMS-FLUOXETINE products distributed in Canada.

Product
PMS-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/7e147b59-dbaf-4a0b-b09b-f5d0bda02db6