Sivem-Irbesartan/HCT 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-75691
Last updated:
2021-05-31
Summary
-
Product:
- Sivem-Irbesartan/HCT 150/12.5 mg Tablet
- Sivem-Irbesartan/HCT 300/12.5 mg Tablet
- Sivem-Irbesartan/HCT 300/25 mg Tablet
- Sivem-Irbesartan/HCT 150/12.5 mg Tablet
- Sivem-Irbesartan/HCT 300/12.5 mg Tablet
- Sivem-Irbesartan/HCT 300/25 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/HCT 150/12.5 mg Tablet
DIN, NPN, DIN-HIM
DIN 02385317
Dosage form
Tablet
Strength
- Irbesartan 150 mg
- Hydrochlorothiazide 12.5 mg
Lot or serial number
JN5054, JV2163, JY7867,KT2519, KT2520
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/HCT 300/12.5 mg Tablet
DIN, NPN, DIN-HIM
DIN 02385325
Dosage form
Tablet
Strength
Irbesartan 300 mg
Hydrochlorothiazide 12.5 mg
Lot or serial number
JP2979, JP2980, JU8206, JU8207
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
C. Sivem-Irbesartan/HCT 300/25 mg Tablet
DIN, NPN, DIN-HIM
DIN 02385333
Dosage form
Tablet
Strength
Irbesartan 300 mg
Hydrochlorothiazide 25 mg
Lot or serial number
JX8881, JX8882, JB0216
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