(WBTV) – A pharmaceutical company has issued a voluntary recall of blood pressure medication Thursday.
Medical officials say the medication is being recalled due to the detection of trace amounts of an “unexpected impurity” found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.
The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes.
The impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
To date, Torrent Pharmaceuticals Limited says they have not received any reports of reactions or incidents related to this recall.
Losartan is used to treat high blood pressure, hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients.
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.
FDA recall notice
The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these 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.
Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at 1-800-912-9561.
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