Torrent is recalling Losartan-containing products that contain NMBA above the acceptable daily intake levels released by the FDA
The nationwide voluntary recall of high blood pressure drug in the US by the Indian drug manufacturing companies continues as federal investigations discovered potential cancer-causing impurities in them.
The US Food and Drug Administration (FDA) recently said that AurobindoPharma USA, Inc has expanded its voluntary recall of medicines used for treating blood pressure to the consumer level. This is an expansion of its earlier recall initiated on December 31, 2018.
Around 38 lots of Valsartan, and Amlodipine and Valsartan tablets were detected with trace amounts of an unexpected impurity, N-nitrosodiethylamine (NDEA), found in the finished drug product. The substance occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
The expansion relates to lots distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC. To date, AurobindoPharma USA, Inc has not received any reports of adverse events related to this recall.
Amlodipine and Valsartan Tablets USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure.
Recently, Ahmedabad-based Torrent Pharmaceuticals Limited has also initiated a voluntary recall of 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the presence of another probable cancer-causing impurity N-Methylnitrosobutyric acid (NMBA) found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Ltd.
Torrent is recalling Losartan-containing products that contain NMBA above the acceptable daily intake levels released by the FDA.
Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with left ventricular hypertrophy.
Last year, similar recalls of hypertension drugs were made by both the companies after the probabale human carcinogen was detected in the API of these products.
Last month, Macleods Pharmaceuticals has also initiated recall of one lot of Losartan Potassium/ Hydrochlorothiazide combination tablets due to the presence of NDEA in the finished product manufactured with API made by Hetero.
Meanwhile, Dr Reddy's Laboratories recently initiated nationwide recall of 10,656 bottles of Divalproex sodium extended-release tablets, USP 250 mg in the US after out of specification results were observed for high dissolution. The medicine is used to treat manic episodes associated with bipolar disorder, epilepsy, and migraine headaches.
Last month, Lupin, another domestic pharma major, has initiated a voluntary recall of 44,640 bottles of Lovastatin tablets USP, 40 mg, packed in 60 and 100 counts bottles in the US and Puerto Rico, after the finished product made with Lovastatin drug substance was out of specification for individual impurity results. Lovastatin is a statin medication used to treat high blood cholesterol and reduce the risk of cardiovascular disease.
BITTER DOSE
- Torrent is recalling Losartan-containing products that contain NMBA above the acceptable daily intake levels released by the FDA
- Last month, Macleods Pharmaceuticals has also initiated recall of one lot of Losartan Potassium/ Hydrochlorothiazide combination tablets
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