Summary

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

Summary

Product: A. Auro-Losartan HCT 50mg/12.5mg B. Auro-Losartan HCT 100mg/12.5mg C. Auro-Losartan HCT 100mg/25mg

Introduction

A. Auro-Losartan HCT 50mg/12.5mg

B. Auro-Losartan HCT 100mg/12.5mg

C. Auro-Losartan HCT 100mg/25mg

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.

Depth of distribution

Wholesalers, Retailers, Healthcare Establishments

Auro-Losartan HCT 50mg/12.5mg

Brand name: Auro-Losartan HCT 50mg/12.5mg
Dosage form: Tablet 
Strength: Losartan Potassium 50mg                                Hydrochlorothiazide 12.5mg
DIN, NPN, DIN-HIM: DIN 02423642
Lot or serial number: ACI5021007B, QX5019009-C, QX5019010-A, QX5019011-B, QX5019009-B
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

Auro-Losartan HCT 100mg/12.5mg

Brand name: Auro-Losartan HCT 100mg/12.5mg
Dosage form: Tablet 
Strength: Losartan Potassium 100mg                                Hydrochlorothiazide 12.5mg
DIN, NPN, DIN-HIM: DIN 02423650
Lot or serial number: ACO1021003A, QY1018012-B, QY1018013-A, QY1018014-A, QY1018015-A, QY1019009-D, QY1018010-A, QY1018011-A, QY1018012-A, QY1019009-A
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

Auro-Losartan HCT 100mg/25mg

Brand name: Auro-Losartan HCT 100mg/25mg
Dosage form: Tablet 
Strength: Losartan Potassium 100mg                                Hydrochlorothiazide 25mg
DIN, NPN, DIN-HIM: DIN 02423669
Lot or serial number: ACI1021007A, QX1019011-A, QX1019010-B, QX1019008-A, QX1019009-B, QX1019007-A
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

For more information

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

Identification number

Identification number: RA-76627