Health product recall

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/12.5mg B. 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

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