FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)

Update [11/22/2019] FDA is alerting patients and health care professionals to two repackagers’ voluntary recalls of ranitidine. The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA).

  • Golden State Medical Supply voluntarily recalled ranitidine capsules (150mg and 300mg), manufactured by Novitium.
  • Precision Dose Inc. voluntarily recalled ranitidine oral solution, USP 150 mg/10 mL, manufactured by Amneal Pharmaceuticals LLC.
FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). The agency posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.
Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.
Consumers taking over-the-counter (OTC) ranitidine may consider using other OTC products approved for their condition. FDA’s tests of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) show no NDMA in the medicines to date.

 

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