Sandoz Canada Losartan/Losartan-HCT Product Recall (2021-09-13)

Health Products

Sep 13, 2021

Basic Details

Alert type: Drug Recall

Category: Drugs

Issue: Product Safety

Audience: General Public, Healthcare Professionals, Hospitals

Department: Health Canada

Hazard classification: Type I

Summary

Product

Losartan 25 mg Tablet

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Products

Lot or serial number	Companies	Brand name	DIN, NPN, DIN-HIM	Dosage form	Strength
KG4858, KU3078, KS3076, KZ7522, KG4859, KS3077, KZ7520	Recalling Firm Sandoz Canada Inc 110 de Lauzon Boucherville J4B 1E6 Quebec CANADA Marketing Authorization Holder Sandoz Canada Inc 110 de Lauzon Boucherville J4B 1E6 Quebec CANADA	Losartan/HCT 100 mg / 25 mg Tablet	DIN 02313383	Tablet	Hydrochlorothiazide 25 mg, Losartan Potassium 100 mg
KF3705, KF3706, KR8908, KS7564, KX6497, LB3649, KR7041, KS5626, KS5627, KX6500	Recalling Firm Sandoz Canada Incorporated 110 Rue De Lauzon Boucherville J4B 1E6 Quebec CANADA Marketing Authorization Holder Sandoz Canada Incorporated 110 Rue De Lauzon Boucherville J4B 1E6 Quebec CANADA	Losartan/HCT 50 mg / 12.5 mg Tablet	DIN 02313375	Tablet	Hydrochlorothiazide 12.5 mg, Losartan Potassium 50 mg
KF3628, KS3893, KT2043, KY9842, LB1657, KF3714, KS3889, KS3890, KT2044, KY9846	Recalling Firm Sandoz Canada Incorporated 110 Rue De Lauzon Boucherville J4B 1E6 Quebec CANADA Marketing Authorization Holder Sandoz Canada Incorporated 110 Rue De Lauzon Boucherville J4B 1E6 Quebec CANADA	Losartan/HCT 100 mg / 12.5 mg Tablet	DIN 02362449	Tablet	Hydrochlorothiazide 12.5 mg, Losartan Potassium 100 mg
KF3629, KS1008, KS1009, KS8837, KT8356, KY8356, KY7473, KS1006, KY7472	Recalling Firm Sandoz Canada Incorporated 110 Rue De Lauzon Boucherville J4B 1E6 Quebec CANADA Marketing Authorization Holder Sandoz Canada Incorporated 110 Rue De Lauzon Boucherville J4B 1E6 Quebec CANADA	Losartan 50 mg Tablet	DIN 02313340	Tablet	Losartan Potassium 50 mg
KF3630, KR6172, KS7551, LA1962, LD1621, LJ2275, KR6171, LA0665	Recalling Firm Sandoz Canada Incorporated 110 Rue De Lauzon Boucherville J4B 1E6 Quebec CANADA Marketing Authorization Holder Sandoz Canada Incorporated 110 Rue De Lauzon Boucherville J4B 1E6 Quebec CANADA	Losartan 100 mg Tablet	DIN 02313359	Tablet	Losartan Potassium 25 mg
KF3703, KF3704, KR0055, KS3238, KV8085, KY3612	Recalling Firm Sandoz Canada Incorporated 110 Rue De Lauzon Boucherville J4B 1E6 Quebec CANADA Marketing Authorization Holder Sandoz Canada Incorporated 110 Rue De Lauzon Boucherville J4B 1E6 Quebec CANADA		DIN 02313332	Tablet	Losartan Potassium 25 mg

Introduction

Losartan 25 mg Tablet
Losartan 50 mg Tablet
Losartan 100 mg Tablet
Losartan/HCT 50 mg / 12.5 mg Tablet
Losartan/HCT 100 mg / 12.5 mg Tablet
Losartan/HCT 100 mg / 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

For more information

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

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