PRO-FLUOXETINE: Affected lots exceed the interim acceptable intake limit for N-nitroso-fluoxetine.
Brand(s)
Last updated
Summary
Product
PRO-FLUOXETINE
Issue
Health products - Product quality
What to do
Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
Distribution
National
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot numbers |
|---|---|---|---|---|---|
| Pro Doc Limitée | PRO-FLUOXETINE 10mg | DIN 02314991 | Capsules | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 10mg | 648684, 648064, 646136, 645497, 644908, 643212 & 641894 |
| Pro Doc Limitée | PRO-FLUOXETINE 20mg | DIN 02315009 | Capsules | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 20mg | 642181 |
Issue
The affected lots exceed the interim acceptable intake limit for N-nitroso-fluoxetine.
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Additional information
Background
Depth of recall: Retailers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Pro Doc Limitée 2925 Boulevard Industriel, Laval, QC, H7L 3W9
Published by
Health Canada
Audience
General public
Healthcare
Industry
Distribution
National
Recall class
Type I
Identification number
RA-77352
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