In a statement released Oct. 2, the FDA said Valisure used higher temperatures in its ranitidine testing than the agency’s approved method. The higher temperatures caused more of the carcinogen, N-nitrosodimethylamine, to form than under normal conditions.
The FDA’s testing, which uses lower temperatures that mimic the reaction ranitidine has when inside a human stomach, showed much lower levels of ranitidine than Valisure’s testing.
However, the agency still called the level of NDMA in the drug “unacceptable.”
Because of Valisure’s misleading results, the FDA asked drugmakers to conduct their own testing and submit samples of their ranitidine products to the agency to be tested.
The statement comes as retailers like Walmart, CVS, Walgreens and Rite Aid remove ranitidine products from their shelves due to the discovery of the cancer-causing substance.
Read the full statement here.
More articles on pharmacy:
Following CVS, Walgreens and Rite Aid pull Zantac from shelves
Telemedicine startup to open first brick-and-mortar pharmacy
Top 10 pharmacy stories in September
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.