Summary

Issue: Product Safety
Audience: General Public, Healthcare Professionals, Hospitals
Category: Drugs
Alert type: Drug Recall
Department: Health Canada
Hazard classification: Type I

Summary

Product: A. Losartan HCT 50mg/12.5mg B. Losartan HCT 100mg/12.5mg C. Losartan HCT 100mg/25mg

Introduction

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

Losartan HCT 50mg/12.5mg

Brand name: Losartan HCT 50mg/12.5mg
Dosage form: Tablet
Strength: Losartan Potassium 50mg                                Hydrochlorothiazide 12.5mg
DIN, NPN, DIN-HIM: DIN 02388960
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

Brand name: Losartan HCT 100mg/12.5mg
Dosage form: Tablet 
Strength: Losartan Potassium 100mg                                Hydrochlorothiazide 12.5mg
DIN, NPN, DIN-HIM: DIN 02388979
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

Brand name: Losartan HCT 100mg/25mg
Dosage form: Tablet 
Strength: Losartan Potassium 100mg                                Hydrochlorothiazide 25mg
DIN, NPN, DIN-HIM: DIN 02388987
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

For more information

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75715a-eng.php

Identification number

Identification number: RA-76643