Health product recall

Irbesartan-HCTZ (2021-01-12)

Starting date:
January 12, 2021
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-74781

Last updated:
2021-01-20

Summary

  • Product:
    Irbesartan-HCTZ

Reason

Presence of impurity 5-(4-(azidomethyl)-[1,1-biphenyl]-2-yl)-1H-tetrazole above the acceptable concentration limit in affected lots.

Depth of distribution

Retailers

Affected products

Irbesartan-HCTZ

DIN, NPN, DIN-HIM

DIN 02365170

Dosage form

Tablet

Strength

  • Hydrochlorothiazide 12.5mg
  • Irbesartan 300mg

Lot or serial number

  • HW0586
  • HW0587

Companies

Recalling Firm

Pro Doc Limitée

2925 Boul. Industriel

Laval

H7L 3W9

CANADA

Marketing Authorization Holder

Pro Doc Limitée

2925 Boul. Industriel

Laval

H7L 3W9

CANADA