Mint-Losartan: Azide Impurity
Last updated
Summary
Product
Mint-Losartan
Issue
Health products - Contamination
What to do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- 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.
Similar recalls or alerts
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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