Mint Pharmaceuticals Mint-Losartan/HCTZ product recall (2021-10-25)

Health Products

Basic Details

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

Summary

Product

A. Mint-Losartan/HCTZ 50mg/12.5mg

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Products

Lot or serial numberBrand nameCompaniesDIN, NPN, DIN-HIMDosage formStrength
2005006807, 2005006808, 2005006809, 2005006810, 2105002149B. Mint-Losartan/HCTZ 100mg/12.5mg
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
DIN 02389665Tablet Losartan 100mg                                                      Hydrochlorohiazide 12.5mg
1805012687, 1805012688, 1805012689, 1805012792, 1905001010, 1905001011, 2005006947, 2005006949, 2005006950, 2005006951, 2005007297, 2005007298, 2005013776, 2105002150C. Mint-Losartan/HCTZ 100mg/25mg
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
DIN 02389673Tablet Losartan 100mg                                                      Hydrochlorohiazide 25mg
2005006959, 2005006960, 2005006961, 2005006962, 2005006963, 2005011154, 2005011156A. Mint-Losartan/HCTZ 50mg/12.5mg
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
DIN 02389657Tablet Losartan 50mg                                                      Hydrochlorohiazide 12.5mg

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 

For more information

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