FDA provides update on its ongoing investigation into ARB drug products: Certain lots of losartan recalled and FDA updates interim limits of nitrosamine impurities in ARBs - Drug Information Update

The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recalls of multiple generic angiotensin II receptor blocker (ARB) drug products used to treat high blood pressure and heart failure. Hetero Labs Ltd. in India has announced a recall of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg). The recalled losartan potassium tablets made by Hetero Labs and distributed by Camber Pharmaceuticals contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity is a known animal and potential human carcinogen. This is the first ARB recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines. FDA also posted an updated table of interim limits for nitrosamine impurities in ARBs. Recent testing of these recalled lots of losartan potassium tablets made by Hetero Labs and distributed by Camber Pharmaceuticals showed NMBA levels higher than the FDA’s interim acceptable intake limits. The FDA’s evaluationsuggests that the nitrosamines found in ARBs may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents. The FDA will continue to update the list of products included in the recall as more information becomes available from ongoing testing. If patients take an ARB drug product, they should check the list periodically, as information may change. For more information, please visit: Losartan Recall and FDA Updates on ARB Recalls.