A voluntary recall of a blood pressure medication has been made by a pharmaceutical company on December 20, 2018. The United states Food and Drug Administration has said that the Torrent Pharmaceuticals Limited is voluntarily recalling two lots of the Losartan Potassium tablets used for blood pressure treatment. According to the medical officials, the medication is being recalled due to the detection of trace amounts of an unexpected impurity that was fund in an active pharmaceutical ingredient that was manufactured by Hetero Labs Limited.
The impurity detected in the API was the N-nitrosodiethylamine (NDEA). It is a substance that occurs naturally in foods, drinking water, industrial process and air pollution. As per the International Agency for Research on cancer classification, the impurity has been classified as a probable human carcinogen. However, the Torrent Pharmaceuticals Limited said that they have not received any reports of reactions or incidents related to this recall.
The drug Losartan is used in treatment of high blood pressure, hypertensive patients with left Ventricular Hypertrophy, hypertension and also for the treatment of nephropathy in Type 2 diabetic patients. The drugs which are subject to recall has been listed and packed in bottles. They can be identified by checking the product name, manufacturer details and batch or the lot number that is written on the bottle containing those products.
• LOSARTAN POTASSIUM TAB, USP 100mg, 30-count bottles, lot/batch BO31C016, expatriation date 04/2019.
• LOSARTAN POTASSIUM TAB, USP 100mg, 90-count bottles, lot/batch BO31C016, expiration date 04/2019.
• LOSARTAN POTASSIUM TAB, USP 100mg,1000-count bottles, lot/batch 4DK3C005, expiration date 04/2019.
The company has also provided a help line for the consumers in case they need to have more information about it. The consumers who have medical questions regarding the recall or anyone who have to report an advert event can contact Torrent Pharmaceuticals Limited at 1-800-912-9561. More information has been mentioned on the official website of the FDA.
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