Health product recall

Auro Pharma Losartan product recall (2021-10-01)

Starting date:
October 1, 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-76569



Last updated:
2021-10-04

Summary

  • Product:
    1. Auro-Losartan 25 mg Tablet
    2. Auro-Losartan 50 mg Tablet
    3. Auro-Losartan 100 mg Tablet
  1. Auro-Losartan 25 mg Tablet
  2. Auro-Losartan 50 mg Tablet
  3. Auro-Losartan 100 mg Tablet

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.

Affected products

A. Auro-Losartan 25 mg Tablet

DIN, NPN, DIN-HIM

DIN 02403323

Dosage form

Tablet

Strength

Losartan Potassium 25 mg

Lot or serial number

AEJ2520001A

Companies

Recalling Firm

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA

Marketing Authorization Holder

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA


B. Auro-Losartan 50 mg Tablet

DIN, NPN, DIN-HIM

DIN 02403331

Dosage form

Tablet

Strength

Losartan Potassium 50 mg

Lot or serial number

AEJ5020001A, AEJ5020002A, AEJ5020003A

Companies

Recalling Firm

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA

Marketing Authorization Holder

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA


C. Auro-Losartan 100 mg Tablet

DIN, NPN, DIN-HIM

DIN 02403358

Dosage form

Tablet

Strength

Losartan Potassium 100 mg

Lot or serial number

AEJ1020001A, AEJ1020002A, AEJ1020003A

Companies

Recalling Firm

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA

Marketing Authorization Holder

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA