Home/Recalls/CANADA-75630
Health CanadaType I

Accel-Ondansetron ODT 4 & 8 mg: Data integrity concerns with product's bioequivalence data that could lead to incorrect dosing.

Published: June 18, 2025Recall ID: 75630Category: generalCountry: Canada
Canada
Safety AlertHealth CanadaCanadaCanada

Accel-Ondansetron ODT 4 & 8 mg: 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.com

Affected Products

Accel-Ondansetron ODT 4 & 8 mg

Additional Source Details

FieldValue
N I D75630
U R Lhttps://recalls-rappels.canada.ca/en/alert-recall/accel-ondansetron-odt-4-8-mg-data-integrity-concerns-product-s-bioequivalence-data
IssueProduct quality
TitleAccel-Ondansetron ODT 4 & 8 mg: Data integrity concerns with product's bioequivalence data that could lead to incorrect dosing.
ProductAccel-Ondansetron ODT 4 & 8 mg
Archived0
CategoryDrugs
Last updated2025-06-18
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.com

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Overview

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