Sivem Pharmaceuticals Losartan HCT product recall (2021-10-13)
- Starting date:
- October 13, 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-76643
Last updated:
2021-10-15
Summary
-
Product:
A. Losartan HCT 50mg/12.5mgB. Losartan HCT 100mg/12.5mg
C. Losartan HCT 100mg/25mg
A. Losartan HCT 50mg/12.5mg
B. Losartan HCT 100mg/12.5mg
C. Losartan HCT 100mg/25mg
Reason
Presence of impurity (5-[4'-[(5-(Azidomethyl)-2-butyl-4-chloro-1H-imidazol-1-yl)methyl]-[1,1'-biphenyl]-2-yl]-1H-tetrazole) above the acceptable concentration limit in affected lots
Depth of distribution
Retailers
Affected products
Losartan HCT 50mg/12.5mg
DIN, NPN, DIN-HIM
DIN 02388960
Dosage form
Tablet
Strength
Losartan Potassium 50mg Hydrochlorothiazide 12.5mg
Lot or serial number
QX5019001-A,QX5019002-A,QX5019003-A,QX5019008-A,QX5019007-A,QX5019005-A,QX5019006-A,QX5019004-A,QX5019010B,ACI5021007A,ACI5021005A,ACI5021006A,ACI5021004B,QX5019009-A,QX5019011-A,ACI5021004A
Companies
- Recalling Firm
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
H4R 2P7
Quebec
CANADA
- Marketing Authorization Holder
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
H4R 2P7
Quebec
CANADA
Losartan HCT 100mg/12.5mg
DIN, NPN, DIN-HIM
DIN 02388979
Dosage form
Tablet
Strength
Losartan Potassium 100mg Hydrochlorothiazide 12.5mg
Lot or serial number
QY1019002-A,QY1019001-A,QY1019003-A,QY1019004-A,QY1019008A,QY1019007B,QY1019009C,ACO1021003AR,ACO1021001B,ACO1021002A,QY1019005-A,QY1019006-A,QY1019007-A,QY1019009-B,ACO1021001A
Companies
- Recalling Firm
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
H4R 2P7
Quebec
CANADA
- Marketing Authorization Holder
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
H4R 2P7
Quebec
CANADA
Losartan HCT 100mg/25mg
DIN, NPN, DIN-HIM
DIN 02388987
Dosage form
Tablet
Strength
Losartan Potassium 100mg Hydrochlorothiazide 25mg
Lot or serial number
QX1019001A,QX1019002A,QX1019005A,QX1019004A,QX1019003A,QX1019003A,QX1019009C,ACI1021005B,ACI1021006A,ACI1021006A,ACI1021006A,ACI1021006A,ACI1021004A
Companies
- Recalling Firm
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
H4R 2P7
Quebec
CANADA
- Marketing Authorization Holder
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
H4R 2P7
Quebec
CANADA