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Category: News
No CommentsU.S. regulators have asked five drugmakers whose diabetes treatments contain high levels of a chemical that can cause cancer to recall their products.
The Food and Drug Administration discovered the chemical impurity N-Nitrosodimethylamine, or NDMA, in some extended-release versions of metformin, the agency said in a statement late Thursday. Bloomberg reported Wednesday that metformin, which is widely used to control high blood sugar in people with type 2 diabetes, recalls were expected.
The FDA said in a letter to pharmacy company Valisure that it had asked Amneal Pharmaceuticals Inc., Actavis Pharma Inc., Apotex Corp., Lupin Pharma and Marksans Pharma Ltd. to recall certain lots of extended-release metformin.
Valisure had submitted a request to the FDA seeking broad recalls of the drug.
Apotex said in a statement that NDMA was found in one lot of its 500 milligram extended-release metformin and that it is recalling all lots of that version as a precaution. The company recalled metformin in Canada earlier this year because of NDMA concerns and had previously stopped making metformin for the U.S. market, though some is still in circulation.