Health product recall

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

Starting date:
September 13, 2021
Posting date:
September 16, 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-76435

Last updated:
2021-09-16

Summary

  • Product:
    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
  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 

Affected products

Losartan 25 mg Tablet

DIN, NPN, DIN-HIM

DIN 02313332

Dosage form

Tablet 

Strength

Losartan Potassium 25 mg

Lot or serial number

KF3703, KF3704, KR0055, KS3238, KV8085, KY3612

Companies

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, NPN, DIN-HIM

DIN 02313340

Dosage form

Tablet 

Strength

Losartan Potassium 50 mg

Lot or serial number

KF3629, KS1008, KS1009, KS8837, KT8356, KY8356, KY7473, KS1006, KY7472

Companies

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, NPN, DIN-HIM

DIN 02313359

Dosage form

Tablet 

Strength

Losartan Potassium 25 mg

Lot or serial number

KF3630, KR6172, KS7551, LA1962, LD1621, LJ2275, KR6171, LA0665

Companies

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, NPN, DIN-HIM

DIN 02313375

Dosage form

Tablet 

Strength

Hydrochlorothiazide 12.5 mg, Losartan Potassium 50 mg

Lot or serial number

KF3705, KF3706, KR8908, KS7564, KX6497, LB3649, KR7041, KS5626, KS5627, KX6500

Companies

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, NPN, DIN-HIM

DIN 02362449

Dosage form

Tablet 

Strength

Hydrochlorothiazide 12.5 mg, Losartan Potassium 100 mg

Lot or serial number

KF3628, KS3893, KT2043, KY9842, LB1657, KF3714, KS3889, KS3890, KT2044, KY9846

Companies

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 / 25 mg Tablet

DIN, NPN, DIN-HIM

DIN 02313383

Dosage form

Tablet 

Strength

Hydrochlorothiazide 25 mg, Losartan Potassium 100 mg

Lot or serial number

KG4858, KU3078, KS3076, KZ7522, KG4859, KS3077, KZ7520

Companies

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