Sanofi-Aventis Avalide Product Recall(2021-06-14)
- Starting date:
- June 14, 2021
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75849
Last updated:
2021-06-16
Summary
-
Product:
A. Avalide 300-12.5 mgB. Avalide 150-12.5 mg
Reason
Presence of impurity 5-(4-(azidomethyl)-[1,1-biphenyl]-2-yl)-1H-tetrazole above the acceptable concentration
limit in affected lot.
Depth of distribution
Retailers, Other (healthcare practioners)
Affected products
A. Avalide 300-12.5 mg
DIN, NPN, DIN-HIM
DIN 02241819
Dosage form
Tablet
Strength
Irbesartan 300 mg
Hydrochlorothiazide 12.5 mg
Lot or serial number
FT01644
Companies
- Recalling Firm
-
Sanofi-Aventis Canada Inc.
2905 Place Louis.R-Renaud
Laval
H7V 0A3
Quebec
CANADA
- Marketing Authorization Holder
-
Sanofi-Aventis Canada Inc.
2905 Place Louis.R-Renaud
Laval
H7V 0A3
Quebec
CANADA
B. Avalide 150-12.5 mg
DIN, NPN, DIN-HIM
DIN 02241818
Dosage form
Tablet
Strength
Irbesartan 150 mg
Hydrochlorothiazide 12.5 mg
Lot or serial number
ET02879, FT01327
Companies
- Recalling Firm
-
Sanofi-Aventis Canada Inc.
2905 Place Louis.R-Renaud
Laval
H7V 0A3
Quebec
CANADA
- Marketing Authorization Holder
-
Sanofi-Aventis Canada Inc.
2905 Place Louis.R-Renaud
Laval
H7V 0A3
Quebec
CANADA