Health Canada recalls [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2024-06-09 11:16 (10 d 02:18 ago) – Posting: # 24026
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Dear all,

on 7 June Health Canada recalled Accel-Ondansetron ODT, Mint-Betahistine and PMS-Pirfenidone tablets due to data integrity concerns.

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.


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