Public recall detail

Mint-Losartan: Azide Impurity

medium
Recall Safety notice
Quick summary

Quick summary: Mint-Losartan: Azide Impurity.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Mint-Losartan: Azide Impurity.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBrand, Mint
ProductMint-Losartan
IssueHealth products - Contamination
Recall classType I
IdentificationRA-63516

Affected products

BrandBrand
ProductProduct Name
DIN / NPN / authorizationMarket Authorization
Dosage formDosage Form
StrengthStrength
LotLot / Batch No.
BrandMint
ProductMint-Losartan/HCTZ 50mg/12.5mg
DIN / NPN / authorizationDIN 02389657
Dosage formTablet
StrengthLosartan 50mg Hydrochlorohiazide 12.5mg
Lot2005006959, 2005006960, 2005006961, 2005006962, 2005006963, 2005011154, 2005011156
BrandMint
ProductMint-Losartan/HCTZ 100mg/12.5mg
DIN / NPN / authorizationDIN 02389665
Dosage formTablet
StrengthLosartan 100mg Hydrochlorohiazide 12.5mg
Lot2005006807, 2005006808, 2005006809, 2005006810, 2105002149
BrandMint
ProductMint-Losartan/HCTZ 100mg/25mg
DIN / NPN / authorizationDIN 02389673
Dosage formTablet
StrengthLosartan 100mg Hydrochlorohiazide 25mg
Lot1805012687, 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.

What you should 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.
Additional official information
AudienceHealth professionals
CategoryHealth products - Drugs
CompaniesMint Pharmaceuticals Inc 6575 Davand Drive, Mississauga, ON, L5T 2M3, Canada
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-63516
Background{}
CompaniesMint Pharmaceuticals Inc 6575 Davand Drive, Mississauga, ON, L5T 2M3, Canada
AudiencesHealth professionals
Source updated2021-10-25

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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