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