Apotex First In US To Recall OTC Ranitidine Tablets Due To NDMA Impurity
Apotex recalls 13 OTC ranitidine tablet products it provided to Walmart, Walgreens and Rite Aid. FDA has no information on plans by nine other firms that, like Apotex, have approved ANDAs for copies of Zantac 75- and 150-mg tablets, which also remain available.
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Whether California court finds Zantac, when marketed containing ranitidine, should have had a Prop 65 label warning could be influenced by dismissal in federal court of class action complaints due to faulty research behind claims that ranitidine causes a carcinogenic substance to form post-production.
SK Capital announced agreement to acquire Apotex, saying it will invest to “support Apotex’s next phase of growth and continued innovation for patient affordability."
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.