OTC Zantac Recall: Sanofi Heeds To Potential Ranitidine Contaminant
Firm opts for recall "as a precautionary measure due to inconsistencies in preliminary test results of the active ingredient used in the US and Canadian products." Other firms marketing ranitidine in US have started recalls due to concerns about NDMA since potential problem became known in September.
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Host of complaints in US courts, seeking damages or alleging ranitidine caused various cancers, followed FDA’s 2020 findings of NDMA levels exceeding allowable limits in some samples provoked Litigation is starting to come to trial, the first set for 22 August in Illinois and a bellwether case due to begin in California in February 2023.
Agency recommends “mitigation strategies” also including designing formulations that incorporate excipients such as sodium carbonate which modify the micro-environment to neutral or basic pH.
Major Europe-based consumer health players GSK, Sanofi, Bayer and Reckitt are all hoping for a sales boost in Q2 following a difficult Q1 due to the almost non-existent cough and cold season. This earnings preview highlights what to look out for as these four firms report their second-quarter results over the coming weeks.