Sandoz Canada Losartan/Losartan-HCT Product Recall (2021-09-13)
Health Products
Sep 13th, 2021 @ 12:00 AM

Basic Details

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

Summary

Product

Losartan 25 mg Tablet

Products

Lot or serial numberCompaniesBrand nameDIN, NPN, DIN-HIMDosage formStrength
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 TabletDIN 02313383Tablet 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 TabletDIN 02313375Tablet 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 TabletDIN 02362449Tablet 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 TabletDIN 02313340Tablet 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 TabletDIN 02313359Tablet 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 02313332Tablet Losartan Potassium 25 mg

Introduction

  1. Losartan 25 mg Tablet
  2. Losartan 50 mg Tablet
  3. Losartan 100 mg Tablet
  4. Losartan/HCT 50 mg / 12.5 mg Tablet
  5. Losartan/HCT 100 mg / 12.5 mg Tablet
  6. 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

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