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Health product recall

APO-Fluoxetine (2015-04-17)

Starting date:: April 17, 2015
Posting date:: April 17, 2015
Type of communication:: Drug Recall
Subcategory:: Drugs
Hazard classification:: Type II
Source of recall:: Health Canada
Issue:: Product Safety
Audience:: General Public, Healthcare Professionals, Hospitals
Identification number:: RA-52993

Reason
Depth of distribution
Affected products

Recalled products

APO-Fluoxetine

Reason

The active pharmaceutical ingredient (API) used in the manufacturing of these lots may not meet the specification for impurity - isobutyl vinyl ketone (IBVK)

Depth of distribution

Retailers

Affected products

A. APO-Fluoxetine

DIN, NPN, DIN-HIM

DIN 02216361

Dosage form

Capsule

Strength

Fluoxetine (Fluoxetine hydrochloride) 20 mg

Lot or serial number

Bottle of 100 Capsules:
- KT8932
- KZ8595
- ME3862
Bottle of 500 Capsules:
- KJ1893

Companies

Recalling Firm

Apotex Inc.

150 Signet Drive

Toronto

M9L 1T9

Ontario

CANADA

Marketing Authorization Holder