Ranitidine Distribution Stops In Canada As Regulators Assess Contamination Threat
Health Canada asks ranitidine H2 blocker firms to halt sales until it gathers more information on NDMA contamination, which may form due to the drug’s instability. At least one marketer, Sandoz, also is recalling its ranitidine products in both Canada and US.
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Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.
As ranitidine suspensions and recalls mount worldwide, US agency says heat of pharmacy lab's test made nitrosamine levels appear high.
CVS, Walgreen suspend sales of brand and store brand ranitidine OTCs while Sanofi confirms it is not recalling Zantac in the US and has no plans to cease manufacturing or distributing.