FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Hetero Labs Recalls Losartan Over Third Impurity

March 11, 2019

The FDA reported finding a third impurity in losartan potassium tablets — N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), a known animal carcinogen — and noted that Indian drugmaker Hetero Labs has recalled dozens of lots of the generic blood pressure drugs.

Hetero recalled 87 lots of losartan potassium tablets that were distributed by Camber Pharmaceuticals in 25mg, 50mg and 100mg dosages.

The recall marks the first for NMBA and the third type of nitrosamine impurity discovered in sartan blood pressure meds, following the discovery of NDMA and NDEA in drug products that contained the active pharmaceutical ingredients valsartan, losartan and irbesartan.

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