Teva Initiates Voluntary Recall of 35 Lots of Lorsartan Tablets

In another industry recall of “sartan”-containing products, Teva Pharmaceuticals USA has initiated a voluntary recall of 35 lots of bulk losartan potassium USP tablets (six lots of 25-mg strength and 29 lots of 100-mg strength) in the US to the patient level.

This recall is due to the detection of an impurity, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s (FDA) interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out, according to information in the recall notice. 

To date (April 26, 2019), Teva said it has not received any reports of adverse events related to the lots being recalled. The company says that no other Teva losartan potassium finished drug products have been identified in the US containing API above the interim specification levels set for NMBA.

Losartan potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The lots were sold exclusively to Golden State Medical Supply of Camarillo, California. Golden State Medical Supply packages this bulk product under its own label and distributes in retail bottles of 30, 90, and 1,000 tablets.

Last month (April 2019), Torrent Pharmaceuticals, an Ahmedabad, India-based pharmaceutical company, expanded its recall for losartan potassium tablets due to detection of the NMBA impurity. 

Recalls of “sartan”-containing products by multiple companies due to impurities arising in the manufacturing processes date back to 2018, which prompted both the FDA and the European Medicines Agency to further investigate these “sartan”-containing products, which are primarily used as anti-hypertensive and cardiovascular drugs. Previously, two other nitrosamine impurities, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), were found in drug products containing the APIs of valsartan, losartan and irbesartan and recalled with further investigation into other sartan products containing candesartan and olmesartan.

Source: Teva Pharmaceuticals and FDA

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