Sanofi-Aventis Avapro 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-75851
Last updated:
2021-06-16
Summary
-
Product:
A. Avapro 75mgB. Avapro 150mg
C. Avapro 300mg
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. Avapro 75mg
DIN, NPN, DIN-HIM
DIN 02237923
Dosage form
Tablet
Strength
Irbesartan 75 mg
Lot or serial number
FT00590
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. Avapro 150mg
DIN, NPN, DIN-HIM
DIN 02237924
Dosage form
Tablet
Strength
Irbesartan 150 mg
Lot or serial number
ET04153, FT01995, FT01238
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
C. Avapro 300mg
DIN, NPN, DIN-HIM
DIN 02237925
Dosage form
Tablet
Strength
Irbesartan 300 mg
Lot or serial number
FT00969, FT01225, FT01226, FT01999, FT04262
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