Accel-Ondansetron ODT 4 & 8 mg: Data integrity concerns with product's bioequivalence data that could lead to incorrect dosing.
Brand(s)
Summary
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.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot |
|---|---|---|---|---|---|
| Accel-Ondansetron ODT 4 mg | Accel-Ondansetron ODT 4 mg | DIN 02535319 | Tablet (Orally Disintegrating) | Ondansetron 4 mg | CDX00123 |
| Accel-Ondansetron ODT 8 mg | Accel-Ondansetron ODT 8 mg | DIN 02535327 | Tablet (Orally Disintegrating) | Ondansetron 8 mg | CEA00123 |
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.
What you should 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
Related recalls and alerts
Additional information
Background
Depth of recall: Retailers, Healthcare Establishments
Details
Accel Pharma Inc.
119 Labrosse Ave, Pointe-Claire
QC, H9R 1A3
History
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