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Mint-losartan: azide impurity

Official notice

25 Oct 2021

Last checked

25 Oct 2021

High riskHealth Canada

An official Health Canada notice concerns Mint-losartan: azide impurity. 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. Published 2021-10-25.

What to do now

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.

Recall number

63516

Official notice

2021-10-25

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63516

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Affected products

Product 1

Brand - Mint, Product Name - Mint-Losartan/HCTZ 50mg/12.5mg, Market Authorization - DIN 02389657, Dosage Form - Tablet, Strength - Losartan 50mg Hydrochlorohiazide 12.5mg, Lot / Batch No. - 2005006959, 2005006960, 2005006961, 2005006962, 2005006963, 2005011154, 2005011156

Product 2

Brand - Mint, Product Name - Mint-Losartan/HCTZ 100mg/12.5mg, Market Authorization - DIN 02389665, Dosage Form - Tablet, Strength - Losartan 100mg Hydrochlorohiazide 12.5mg, Lot / Batch No. - 2005006807, 2005006808, 2005006809, 2005006810, 2105002149

Product 3

Brand - Mint, Product Name - Mint-Losartan/HCTZ 100mg/25mg, Market Authorization - DIN 02389673, Dosage Form - Tablet, Strength - Losartan 100mg Hydrochlorohiazide 25mg, Lot / Batch No. - 1805012687, 1805012688, 1805012689, 1805012792, 1905001010, 1905001011, 2005006947, 2005006949, 2005006950, 2005006951, 2005007297, 2005007298, 2005013776, 2105002150

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Mint-losartan.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

63516

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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