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

Report a Concern
Starting date:
October 25, 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-76745

Last updated:

Summary

  • Product: A. Mint-Losartan/HCTZ 50mg/12.5mg B. Mint-Losartan/HCTZ 100mg/12.5mg C. Mint-Losartan/HCTZ 100mg/25mg

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 

Affected products

A. Mint-Losartan/HCTZ 50mg/12.5mg

DIN, NPN, DIN-HIM

DIN 02389657

Dosage form

Tablet 

Strength

Losartan 50mg                                                      Hydrochlorohiazide 12.5mg

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

DIN, NPN, DIN-HIM

DIN 02389665

Dosage form

Tablet 

Strength

Losartan 100mg                                                      Hydrochlorohiazide 12.5mg

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

DIN, NPN, DIN-HIM

DIN 02389673

Dosage form

Tablet 

Strength

Losartan 100mg                                                      Hydrochlorohiazide 25mg

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