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Health product recall

Apo-Rosuvastatin (2013-10-28)

Starting date:
October 28, 2013
Posting date:
November 21, 2013
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-36695

Recalled products

A. Apo-Rosuvastatin

Reason

High out of specification result for total impurities at the 15-month time point.

Depth of distribution

Wholesalers/distributors in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Nunavut, Ontario, Quebec, Saskatchewan.

Affected products

A. Apo-Rosuvastatin

DIN, NPN, DIN-HIM
DIN 02338009
Dosage form

Tablets

Strength
  • 40 mg
Lot or serial number
  • KA8816
  • KA8807
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

Date modified: