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

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: 2021-10-29

Summary

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

• Reason
• Depth of distribution
• Affected products

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