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FDA Investigates NDMA Impurity in Metformin Diabetes Medicines

FDA has recently been investigating the presence of nitrosamines in drug products. During the course of the investigation, ranitidine (also known as Zantac) was found to contain small amounts of N-Nitrosodimethylamine (NDMA). In order to ensure drug products continue to meet stringent quality standards, FDA has been conducting an ongoing investigation into the presence of nitrosamines in other drug products, including metformin.

Low Levels of NDMA Found in Metformin Outside the U.S.

Low levels of NDMA have been reported in some metformin diabetes medicines in countries other than the U.S. The levels of NDMA in metformin that have been seen outside the U.S. are within the range that naturally occurs in some food and water, based on available information. While some agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls in the U.S. at this time.

Lab Testing of Metformin for NDMA Impurity is Ongoing

FDA is currently investigating whether metformin in the U.S. market contains NDMA. Furthermore, they are also investigating whether NDMA is present in metformin above the daily intake limit of 96 nanograms. The agency is working with manufacturers to test samples of metformin sold in the U.S. and if high levels of NDMA are found during the investigation, they will recommend recalls of the drug.

Review and Testing of Drug Products for NDMA and Nitrosamine Impurities Continues

As FDA’s investigation and testing of drug products for NDMA and nitrosamine impurities continues, low levels of nitrosamines may be found in additional drugs as data generated from FDA investigations along with data reported by other regulatory agencies is reviewed. FDA’s investigations have indicated that the source of NDMA can be linked to the manufacturing process of a drug, its chemical structure, or the conditions under which the drug product is stored or packaged.

Avomeen Can Test Metformin and Other Drug Products for NDMA Impurities

Avomeen’s industry and scientific experts tested a number of lots of ranitidine for the FDA’s initial NDMA impurity investigation, and are ready to analyze lots of additional drug product for NDMA and other impurities. Speak to a regulatory expert or get a quote for NDMA impurity testing.

Additional Resources

We explore the initial FDA statement and investigation into the NDMA impurities in ranitidine in our blog, New FDA Statement on NDMA Impurities in Drug Products.

FDA now requires manufacturers to test each lot of ranitidine medication prior to release to patients and consumers. Check out our blog for more information.



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