- The FDA recommends drug manufacturers and third-party laboratories use a liquid chromatography-high-resolution mass spectrometry (LC-HRMS) testing method to assess levels of N-nitrosodimethylamine (NDMA) contamination in ranitidine products.
Why this matters
- Results reported by 1 laboratory are based on a method the FDA recommends for assessing contamination in angiotensin II receptor blockers (ARBs); when applied to ranitidine, this method boosts NDMA levels and skews test results.
What manufacturers should do
- The agency asks ranitidine manufacturers to test their products using the LC-HRMS method and to send product samples to FDA scientists for additional testing.
What FDA is doing
- The FDA first alerted patients and providers to ranitidine-NDMA contamination in mid-September 2019, and by the end of that month had announced voluntary recalls of prescription capsules distributed to wholesalers and retail pharmacies, as well as over-the-counter tablets sold nationwide by Rite Aid, Walgreens, and Walmart stores.
- The agency continues testing ranitidine products from multiple manufacturers and assessing potential risks to patients exposed to the drug; the agency will provide more information as it becomes available.