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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

Recalled products

  1. 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
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

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