Health product recall

Sanis Health Losartan / Losartan-HCTZ Product Recall (2021-09-10)

Starting date:
September 10, 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-76429

Last updated:
2021-09-16

Summary

  • Product:
    1. Losartan 25 mg Tablet
    2. Losartan 50 mg Tablet
    3. Losartan 100 mg Tablet
    4. Losartan/HCTZ 100 mg / 12.5 mg Tablet
    5. Losartan/HCTZ 100 mg / 25 mg Tablet
    6. Losartan/HCTZ 100 mg / 50 mg Tablet
  1. Losartan 25 mg Tablet
  2. Losartan 50 mg Tablet
  3. Losartan 100 mg Tablet
  4. Losartan/HCTZ 100 mg / 12.5 mg Tablet
  5. Losartan/HCTZ 100 mg / 25 mg Tablet
  6. Losartan/HCTZ 100 mg / 50 mg Tablet

Reason

Presence of 5-(azidomethyl)-2-butyl-4-chloro-1H-imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole impurity

Depth of distribution

Retailers 

Affected products

Losartan 25 mg Tablet

DIN, NPN, DIN-HIM

DIN 02388863

Dosage form

Tablet 

Strength

Losartan Potassium 25mg

Lot or serial number

KS3239, KV8086, LH0370

Companies

Recalling Firm

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Losartan 50 mg Tablet

DIN, NPN, DIN-HIM

DIN 02388871

Dosage form

Tablet 

Strength

Losartan Potassium 50mg

Lot or serial number

KS1007, KS8836, KY7469, LB2316

Companies

Recalling Firm

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Losartan 100 mg Tablet

DIN, NPN, DIN-HIM

DIN 02388898

Dosage form

Tablet

Strength

Losartan Potassium 100mg

Lot or serial number

KS9031, KY5728, LJ2274

Companies

Recalling Firm

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Losartan/HCTZ 100 mg / 12.5 mg Tablet

DIN, NPN, DIN-HIM

DIN 02427656

Dosage form

Tablet 

Strength

Hydrochlorothiazide 12.5mg, Losartan Potassium 100mg

Lot or serial number

KS9114, LB1656, LG7830

Companies

Recalling Firm

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Losartan/HCTZ 100 mg / 25 mg Tablet

DIN, NPN, DIN-HIM

DIN 02427664

Dosage form

Tablet 

Strength

Hydrochlorothiazide 25mg, Losartan Potassium 100mg

Lot or serial number

KS3078, KU3077, KZ7521

Companies

Recalling Firm

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Losartan/HCTZ 100 mg / 50 mg Tablet

DIN, NPN, DIN-HIM

DIN 02427648

Dosage form

Tablet 

Strength

Hydrochlorothiazide 50mg, Losartan Potassium 100mg

Lot or serial number

KS7557, KX6499, LB3650

Companies

Recalling Firm

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Sanis Health

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA