Vivimed is recalling 19 lots of losartan potassium tablets of 25 mg, 50 mg and 100 mg because of the detection of an impurity — N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) — that is above the Food & Drug Administration's interim acceptable exposure limit of 9.82 ppm. Based on the available information, the FDA wrote in its recall summary, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.
These losartan lots are made by Vivimed at its plant in Alathur, Chennai, India, and distributed by Heritage Pharmaceuticals Inc. in East Brunswick, New Jersey.
Losartan belongs to a class of medicines used for treating high blood pressure called angiotensin II receptor blockers. Some generic versions of other ARBs, such as valsartan and irbesartan, have also been recalled.
The identifying National Drug Code numbers associated with the Heritage distributed product are:
- Losartan tablets 25 mg: 90 count: NDC 23155-644-09
- Losartan tablets 50 mg: 90 count: NDC 23155-645-09, 1000-count: NDC 23155-645-10
- Losartan tablets 100 mg: 90-count- NDC 23155-646-09, 1000-count: NDC 23155-646-10
Since July 2018, the FDA has announced voluntary recalls of blood pressure and heart medications from Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries, Mylan Pharmaceuticals, Prinston Pharmaceuticals, Macleods Pharmaceuticals Limited, Camber Pharmaceuticals and Torrent.
To alleviate shortages caused by these recalls, the FDA in March approved a generic form of the blood pressure medication Diovan, or valsartan.
Consumers with questions regarding this recall can contact Vivimed c/o Inmar at 1-877-861-3811, 9 a.m. – 5 p.m. EST Monday – Friday.
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