Sivem-Irbesartan Product Recall (2021-05-26)
- Starting date:
- May 26, 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-75689
Last updated:
2021-05-31
Summary
-
Product:
- Sivem-Irbesartan 150 mg Tablet
- Sivem-Irbesartan 300 mg Tablet
- Sivem-Irbesartan 150 mg Tablet
- Sivem-Irbesartan 300 mg Tablet
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
-
Sivem-Irbesartan 150 mg Tablet
DIN, NPN, DIN-HIM
DIN 02385295
Dosage form
Tablet
Strength
Irbesartan 150mg
Lot or serial number
KC7215
Companies
- Recalling Firm
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
- Marketing Authorization Holder
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
B. Sivem-Irbesartan 300 mg Tablet
DIN, NPN, DIN-HIM
DIN 02385309
Dosage form
Tablet
Strength
Irbesartan 300mg
Lot or serial number
KF8325
Companies
- Recalling Firm
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
- Marketing Authorization Holder
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA