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
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
- Mint Pharmaceuticals Inc., by contacting Olenka Crewe at Mint Pharmaceuticals Inc. Scientific Affairs by calling 416-803-9151, or by email at olenkac@mintpharmaceuticals.com
- Pharmascience Inc. by calling, toll-free, at 1-800-340-9735, or by email at customercarePms@pharmascience.com
Additional information
Previous recalls or alerts
Background
Depth of recall: Retailers, Healthcare Establishments
Details
Accel Pharma Inc.
119 Labrosse Ave, Pointe-Claire
QC, H9R 1A3
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