The Food and Drug Administration has expanded an already widespread recall of common blood pressure and heart failure medications.
The latest recall is for 38 lots of Valsartan and Amlodipine and Valsartan tablets produced by AurobindoPharma USA due to "the detection of trace amounts of an unexpected impurity found in the finished drug".
The Food and Drug Administration (FDA) announced last week the latest in an already widespread recall of common blood pressure and heart failure medications.
That impurity is N-nitrosodiethylamine (NDEA), which is classified as a "probable human carcinogen". Incidentally, Hetero Labs Limited was also listed as the source of the contamination in both recalls.
Almost 90 lots of Losartan potassium tablets made by Hetero Labs in India and distributed by Camber Pharmaceuticals were recalled Thursday due the discovery of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a probable carcinogen.
The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs.
The product subject to the recall is listed below.
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It's the first ARB recall involving the presence of NMBA, which is the third type of nitrosamine impurity detected in the medications, the FDA said.
"That said, any presence of such impurities in drug products is not acceptable", FDA Commissioner Scott Gottlieb said in the statement.
"We're continuing to share these testing methods with worldwide regulators, industry and the public to help manufacturers and other regulators evaluate these products for any potential nitrosamine impurity".
And then there's Macleods Pharmaceuticals Limited, which announced on February 22, 2019, that it was initiating a recall on just one of its lots of Losartan tablets after traces of NDEA were detected by officials.
As for the latest recall, the FDA has reminded patients prescribed an ARB medication from a recalled lot to continue taking their medicine until their doctor or pharmacist provides a replacement or offers a different treatment option.
Other companies that announced recalls in December 2018 include Mylan Pharmaceuticals and Torrent Pharmaceuticals, whose products contained NDEA.