UPDATE: June 17, 2025 - Accel Pharma can resume sale of undistributed units of lots CDX00123 and CEA00123 after bioequivalence test data confirm Accel-Ondansetron ODT is safe and effective to use After reviewing the bioequivalence test data provided by Accel Pharma Inc., Health Canada has confirmed that Accel-Ondansetron ODT (4 mg and 8 mg tablets) are equivalent to their brand name counterparts and are safe and effective to use. As a result, the company has resumed the sale of undistributed units from lots CDX00123 and CEA00123 (listed above). Original Advisory: June 7, 2024 Three companies (Accel Pharma Inc., Mint Pharmaceuticals Inc., and Pharmascience Inc.) are recalling all lots listed in the Affected Products table (above) due to concerns about the integrity of tests that are used to show that their generic prescription drugs work the same as brand-name versions. Health Canada's authorization of the affected products relied on the bioequivalence test data. Bioequivalence data is used to demonstrate that generic drugs are equivalent to their brand-name counterparts. The bioequivalence tests were conducted by Synapse Labs Pvt. Ltd., a contract research organization in Pune, Maharashtra, India. An inspection by a member of the European Medicines Agency , a trusted regulatory partner, found that data produced by Synapse Labs can no longer be relied upon to show this bioequivalence. As a result, the affected products can no longer be considered safe and effective. At Health Canada's request, the companies have stopped sale and have recalled all lots of the affected products until they can provide additional information to demonstrate that the products are safe and effective. Health Canada is monitoring the effectiveness of the recalls and will take appropriate and timely action if any new health risks are identified.
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