US health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India’s Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension.
Nearly 90 lots of Losartan potassium tablets made by Hetero Labs in India and distributed by Camber Pharmaceuticals were recalled Thursday due to the discovery of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a probable carcinogen.
“Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug’s active pharmaceutical ingredients,” said FDA Commissioner Scott Gottlieb, M.D., in a statement.
The U.S. Food and Drug Administration weighed in on the recalls of multiple generic angiotensin II receptor blocker, or ARB, drugs, on Friday, saying the impurities may be the result of chemical reactions that occur in the drugmaking process or from the reuse of materials, such as solvents.
“Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products,” FDA Commissioner Scott Gottlieb said in a statement.
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