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Health product recall

Apo-Telmisartan/HCTZ (2017-05-02)

Starting date:
May 2, 2017
Posting date:
June 22, 2017
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-63722

Reason

Out of specification result for dissolution during shelf life testing of the affected lots

Depth of distribution

Wholesalers and Retailers in AB, BC, MB, NB, NF, ON, QC, and SK

Affected products

Apo-Telmisartan/HCTZ

DIN, NPN, DIN-HIM

DIN 02420023

Dosage form

Tablet

Strength

  • 80 mg Telmisartan
  • 12.5 mg Hydrochlorothiazide

Lot or serial number

  • MM2211
  • MM2213

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: