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. Mint-Losartan/HCTZ 50mg/12.5mg B. Mint-Losartan/HCTZ 100mg/12.5mg C. Mint-Losartan/HCTZ 100mg/25mg

Introduction

A. Mint-Losartan/HCTZ 50mg/12.5mg

B. Mint-Losartan/HCTZ 100mg/12.5mg

C. Mint-Losartan/HCTZ 100mg/25mg

Reason

Presence of impurity Losartan Azide  ((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

Retailers, Wholesalers 

A. Mint-Losartan/HCTZ 50mg/12.5mg

Brand name: A. Mint-Losartan/HCTZ 50mg/12.5mg
Dosage form: Tablet 
Strength: Losartan 50mg                                                      Hydrochlorohiazide 12.5mg
DIN, NPN, DIN-HIM: DIN 02389657
Lot or serial number: 2005006959, 2005006960, 2005006961, 2005006962, 2005006963, 2005011154, 2005011156
Companies:

Recalling Firm

Mint Pharmaceuticals Inc

6575 Davand Drive

Mississauga

L5T 2M3

Ontario

CANADA

Marketing Authorization Holder

Mint Pharmaceuticals Inc

6575 Davand Drive

Mississauga

L5T 2M3

Ontario

CANADA

B. Mint-Losartan/HCTZ 100mg/12.5mg

Brand name: B. Mint-Losartan/HCTZ 100mg/12.5mg
Dosage form: Tablet 
Strength: Losartan 100mg                                                      Hydrochlorohiazide 12.5mg
DIN, NPN, DIN-HIM: DIN 02389665
Lot or serial number: 2005006807, 2005006808, 2005006809, 2005006810, 2105002149
Companies:

Recalling Firm

Mint Pharmaceuticals Inc

6575 Davand Drive

Mississauga

L5T 2M3

Ontario

CANADA

Marketing Authorization Holder

Mint Pharmaceuticals Inc

6575 Davand Drive

Mississauga

L5T 2M3

Ontario

CANADA

C. Mint-Losartan/HCTZ 100mg/25mg

Brand name: C. Mint-Losartan/HCTZ 100mg/25mg
Dosage form: Tablet 
Strength: Losartan 100mg                                                      Hydrochlorohiazide 25mg
DIN, NPN, DIN-HIM: DIN 02389673
Lot or serial number: 1805012687, 1805012688, 1805012689, 1805012792, 1905001010, 1905001011, 2005006947, 2005006949, 2005006950, 2005006951, 2005007297, 2005007298, 2005013776, 2105002150
Companies:

Recalling Firm

Mint Pharmaceuticals Inc

6575 Davand Drive

Mississauga

L5T 2M3

Ontario

CANADA

Marketing Authorization Holder

Mint Pharmaceuticals Inc

6575 Davand Drive

Mississauga

L5T 2M3

Ontario

CANADA

For more information

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

Identification number

Identification number: RA-76745