Impurity in Blood Pressure Medicines- Company Recall
A pharmaceutical firm has issued a voluntary recall of blood strain remedy Thursday. In response to the FDA (United States Food and Drug Administration), Torrent Pharmaceuticals Limited voluntarily recalls two plenty of Losartan potassium tablets,
Medical officers say the medicine is being remembered as a result of the detection of hint quantities of a “surprising impurity” present in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected within the API is N-nitrosodiethylamine (NDEA), which is a substance that happens naturally in certain foods, consuming water, air pollution, and industrial processes.
The impurity has been categorized as a possible human carcinogen as per International Agency for Research on Cancer (IARC) classification. To this point, Torrent Pharmaceuticals Limited says they haven’t acquired any reviews of reactions or incidents associated with this recall. Losartan is used to deal with hypertension, hypertension, hypertensive sufferers with Left Ventricular Hypertrophy and for the remedy of nephropathy in Sort 2 diabetic sufferers.
The products subject to recall are listed beneath and packaged in bottles. The product will be recognized by checking the product title, producer particulars, and batch or lot quantity on the bottle containing these products.
- LOSARTAN POTASSIUM TAB, USP 100mg, 30-rely bottles, lot/batch BO31C016, expatriation date 04/2019.
- LOSARTAN POTASSIUM TAB, USP 100mg, 90-rely bottles, lot/batch BO31C016, expiration date 04/2019.
- LOSARTAN POTASSIUM TAB, USP 100mg,1000-rely bottles, lot/batch 4DK3C005, expiration date 04/2019.
Customers with medical questions relating to this recall or to report an adversarial occasion can contact Torrent Pharmaceuticals Limited at 1-800-912-9561.