Testing Ranitidine With Too Much Heat Could Generate NDMA, FDA Says
FDA recommends using "Liquid Chromatography-High Resolution Mass Spectrometry Method" for testing ranitidine rather than method apparently used by online pharmacy Valisure, which asked agency to halt production and order recalls.
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New Hope Network postponed Natural Products Expo West trade show due to coronavirus; NPA supports Accurate Labels Act; American Health Packaging recalls OTC ranitidine; and FDA seeks input on topics for upcoming International Cooperation on Cosmetics Regulation meeting.
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.
Recent updates to FDA recalls database also include single lots of three package sizes of Johnson’s Baby Powder after testing found sub-trace levels of chrysotile asbestos contamination and 5,720 bottles of homeopathic OTCs made in India for West Virginia firm Washington Homeopathic Products Inc. at a facility noncompliant with the agency’s good manufacturing practices regulations.