The US Food and Drug Adminsitration (FDA) and Torrent Pharmaceuticals Limited expanded for the fifth time a warning against using a common blood pressure medication.
The medication, Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, is being recalled to the consumer level due to detection of trace amounts of an impurity.
The expanded recall includes three more lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP. These lots contain N-Methylnitrosobutyric acid (NMBA) above the accepted daily intake levels recommended by the FDA, which has been linked to cancer.
Losartan is used to treat nephropathy in Type 2 diabetic patients as well as hypertension and hypertensive patients with Left Ventricular Hypertrophy.
Patients taking the affected pills should continue taking their medication and contact their pharmacist or physician.
The list of recalled products includes:
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E009, expiration date: 12/31/2020
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E009, expiration date: 12/31/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E018, expiration date: 02/28/2021
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D051, expiration date: 11/30/2020
13668-118-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. 4P04D007, expiration date: 07/31/2020
The company has notified its distributors and retail customers.