Sivem-Losartan 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-75693
Last updated:
2021-05-31
Summary
-
Product:
- Sivem-Losartan 25 mg Tablet
- Sivem-Losartan 50 mg Tablet
- Sivem-Losartan 100 mg Tablet
- Sivem-Losartan 25 mg Tablet
- Sivem-Losartan 50 mg Tablet
- Sivem-Losartan 100 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-Losartan 25 mg Tablet
DIN, NPN, DIN-HIM
DIN 02388790
Dosage form
Tablet
Strength
Losartan Potassium 25mg
Lot or serial number
0050919, 0060919, 0070919, 0080919, 0080919A, 0101019, 0101019A, 0030120, 0040120, 0080620, 0090620
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-Losartan 50 mg Tablet
DIN, NPN, DIN-HIM
DIN 02388804
Dosage form
Tablet
Strength
Losartan Potassium 50mg
Lot or serial number
1121018, 1131018, 1130819, 1140819, 1150819, 1160819, 1170919, 1180919, 1070220, 1080220, 1090220, 1100220, 1110220, 1060220, 1120620
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-Losartan 100 mg Tablet
DIN, NPN, DIN-HIM
DIN 02388812
Dosage form
Tablet
Strength
Losartan Potassium 100mg
Lot or serial number
2070817, 2040218, 2101018, 2020219, 2030219, 2040219, 2090619, 2100919, 2110919, 2120919, 2130919, 2140919, 2151119, 2050420, 2060420
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