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Health Canada Health products

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

Issued June 18, 2025
Issue
UPDATE: June 17, 2025 - Accel Pharma can resume sale of undistributed unit of lots CDX00123 & CEA00123 after bioequivalence test data confirm Accel-Ondansetron ODT is safe and effective to use. Data integrity concerns with product's bioequivalence data that could lead to incorrect dosing.
Hazard description
Product quality
What to do
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
Product
Product name
Accel-Ondansetron ODT 4 & 8 mg
Reference
ID
RA-75630