Torrent Pharmaceuticals Limited is the latest pharmaceutical company to recall blood pressure medication.
According to a Dec. 20 company announcement posted by the Food and Drug Administration, two lots of Losartan potassium tablets are being voluntarily recalled at the consumer level. The recall is "due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited."
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The impurity, called N-nitrosodiethylamine (NDEA) is found naturally in certain foods, air pollution, drinking water and industrial processes. It has been classified by the International Agency for Research on Cancer as a probable human carcinogen. It’s the same impurity that led Sandoz Inc. to recall losartan potassium hydrochlorothiazide.
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According to the company, there have not been reports of reactions or incidents related to the impurity.
In addition to being used to treat high blood pressure, the anti-hypertensive drug is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in people with Type 2 diabetes.
“Patients who are on Losartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication,” recall said.
Products recalled are below:
- 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.
Consumers with questions about the recall or those who need to report reactions or adverse events from the medicine can call 1-800-912-9561. More information on the recall and points of contact is at FDA.gov.
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