Health product recall

Mint-Losartan: Azide Impurity

Last updated

Summary

Product
Mint-Losartan
Issue
Health products - Contamination
What to do
  1. Verify if your product is affected.
  2. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
  3. Contact the recalling firm if you have any questions about the recall.
  4. Report any health product related side effects to Health Canada.
  5. Report any other health product safety complaints to Health Canada.
Audience
Health professionals

Affected products

Brand Product Name Market Authorization Dosage Form Strength Lot / Batch No.
Mint Mint-Losartan/HCTZ 50mg/12.5mg DIN 02389657 Tablet Losartan 50mg Hydrochlorohiazide 12.5mg 2005006959, 2005006960, 2005006961, 2005006962, 2005006963, 2005011154, 2005011156
Mint Mint-Losartan/HCTZ 100mg/12.5mg DIN 02389665 Tablet Losartan 100mg Hydrochlorohiazide 12.5mg 2005006807, 2005006808, 2005006809, 2005006810, 2105002149
Mint Mint-Losartan/HCTZ 100mg/25mg DIN 02389673 Tablet Losartan 100mg Hydrochlorohiazide 25mg 1805012687, 1805012688, 1805012689, 1805012792, 1905001010, 1905001011, 2005006947, 2005006949, 2005006950, 2005006951, 2005007297, 2005007298, 2005013776, 2105002150

Issue

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.

Additional information

Background

Depth of Recall: Retailers, Wholesalers

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies

Mint Pharmaceuticals Inc

6575 Davand Drive,

Mississauga, ON, L5T 2M3, Canada

Published by
Health Canada
Audience
Health professionals
Recall class
Type I
Identification number
RA-63516