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

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