CanadaApotex Apo‑Fluoxetine capsules are recalled: 20 mg (DIN 02216361) lots VM4608 and VM4612, and 10 mg (DIN 02216353) lot VM4598. The recall was issued because impurities are out of specification and out of trend; verify whether your product is one of the affected lots, consult your healthcare provider before discontinuing use, contact the recalling firm with questions, and report any side effects or other safety complaints to Health Canada.
What's being recalled
Depth of recall: Retailers
Companies: Apotex Inc., 150 Signet Drive, Toronto ON, M9L 1T9.
How to identify it
Brand: Apotex; Product Name: Apo-Fluoxetine 20mg; Market Authorization: DIN 02216361; Dosage Form: Capsule; Strength: Fluoxetine (Fluoxetine hydrochloride) 20mg; Lot: VM4608, VM4612
Brand: Apotex; Product Name: Apo-Fluoxetine 10mg; Market Authorization: DIN 02216353; Dosage Form: Capsule; Strength: Fluoxetine (Fluoxetine hydrochloride) 10mg; Lot: VM4598
The hazard
The impurities are out of specification and out of trend in the affected lot.
What to 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.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)