Accel-ondansetron Odt 4 & 8 Mg: Data Integrity Concerns With Product's Bioequivalence Data That Could Lead To Incorrect Dosing.
Accel-Ondansetron ODT tablets in 4 mg and 8 mg strengths are being recalled across Canada due to data integrity issues with bioequivalence testing that could result in incorrect dosing. The manufacturer found problems with how the product's bioequivalence data was generated, which affects confidence in whether patients receive the correct amount of medication. This is classified as a serious Class I recall and affects all Canadian distributions of this product.
- Product
- Accel-Ondansetron ODT 4 & 8 mg
- Reason
- Product quality
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DRUGS
- Recall date
- 2025-06-18
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DRUGS
Recall details on Nibble Recalls: https://trynibble.app/recalls/1aec7979-c978-4cf8-8465-30eb20337c9d