Home/Recalls/CANADA-75634
Health CanadaType I

Mint-Betahistine 8, 16 & 24mg: Data integrity concerns with product's bioequivalence data that could lead to incorrect dosing.

Published: June 6, 2024Recall ID: 75634Category: generalCountry: Canada
Canada
Safety AlertHealth CanadaCanadaCanada

Mint-Betahistine 8, 16 & 24mg: Data integrity concerns with product's bioequivalence data that could lead to incorrect dosing.

Recalling Firm: Drugs and health products

Reason for Recall / Hazard

Product quality

Product Description & Identification

Return the affected products to your local pharmacy for a replacement, and for proper disposal. If you are unsure whether your product is affected, check with your pharmacy.Consult a health care professional if you have used the affected product and you have health concerns.Report any health product-related side effects or complaints to Health Canada.Contact the companies if you have questions about their recall:Accel Pharma Inc., by contacting Betty Cory at Accel Quality Assurance by calling 416-271-4775, or by email at bcory@regxia.comMint Pharmaceuticals Inc., by contacting Olenka Crewe at Mint Pharmaceuticals Inc. Scientific Affairs by calling 416-803-9151, or by email at olenkac@mintpharmaceuticals.comPharmascience Inc. by calling, toll-free, at 1-800-340-9735, or by email at customercarePms@pharmascience.com

Affected Products

Mint-Betahistine 8, 16 & 24mg

Additional Source Details

FieldValue
N I D75634
U R Lhttps://recalls-rappels.canada.ca/en/alert-recall/mint-betahistine-8-16-24mg-data-integrity-concerns-product-s-bioequivalence-data-could
IssueProduct quality
TitleMint-Betahistine 8, 16 & 24mg: Data integrity concerns with product's bioequivalence data that could lead to incorrect dosing.
ProductMint-Betahistine 8, 16 & 24mg
Archived0
CategoryDrugs
Last updated2024-06-06
OrganizationDrugs and health products
Recall classType I
What you should doReturn the affected products to your local pharmacy for a replacement, and for proper disposal. If you are unsure whether your product is affected, check with your pharmacy.Consult a health care professional if you have used the affected product and you have health concerns.Report any health product-related side effects or complaints to Health Canada.Contact the companies if you have questions about their recall:Accel Pharma Inc., by contacting Betty Cory at Accel Quality Assurance by calling 416-271-4775, or by email at bcory@regxia.comMint Pharmaceuticals Inc., by contacting Olenka Crewe at Mint Pharmaceuticals Inc. Scientific Affairs by calling 416-803-9151, or by email at olenkac@mintpharmaceuticals.comPharmascience Inc. by calling, toll-free, at 1-800-340-9735, or by email at customercarePms@pharmascience.com

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Overview

  • Recalling FirmDrugs and health products
  • Risk LevelType I
Recall Hazard Severity
Caution (Class III)
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