Contamination In Common OTC Antacid Adds To FDA's API Impurity Concerns
FDA assessing contamination of Rx and OTC H2 blocker ranitidine to determine steps it should take. The contaminant, NDMA, is dangerous when consumed in large quantities, but has been found in H2 blockers at levels that don't pose a risk, FDA says.
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Zantac marketer Sanofi says it’s unclear whether the product eventually will relaunch. In other recent consumer health and beauty recalls in US, a vitamin C-containing face mask is recalled following a “spike in complaints” about skin irritation and the insides of tubes of sodium chloride ophthalmic ointments made for Walgreens and CVS were found with materials used to make the containers.
"FDA’s failure to stop companies from selling ranitidine makes the United States government complicit in exposing infants and adults to the risk of cancer," says Rep. DeLauro in letter to FDA and HHS. She also re-introduced legislation proposing FDA have mandatory recall authority for drugs.
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.