US FDA Requests Ranitidine Removal But Also Encourages Research For Stable Formulations
FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.
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“What started a couple years ago with the discovery of nitrosamine in blood pressure and heart medicine has since evolved to benzene in hand sanitizer and sunscreen,” says Sedgwick International’s Amanda Combs about “Valisure scenario.”
Widespread problems FDA found in hand sanitizers resulted from businesses unfamiliar with drug production entering the space after agency eased manufacturing standards to encourage increased supplies. Heartburn remedy ranitidine noted due to its chemical profile, not errors by manufacturers.
Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.