The FDA has advised consumers that Torrent Pharmaceuticals is voluntarily expanding its blood pressure medication recall over the presence of an impurity that may trigger the development of cancer in some patients. The expansion covers another two lots of Losartan Potassium / Hydrochlorothiazide tablets USP, as well as three lots of Losartan Potassium tablets USP.
As with the original recall, the newly recalled lots may be contaminated with trace amounts of an impurity called N-Methylnitrosobutyric acid (NMBA) that are present at levels higher than what the FDA considers acceptable for daily exposure. This substance occurs naturally in some cases and is considered a probable carcinogen in humans, meaning it is a potential cancer risk.
The FDA is once again advising patients who have some of the recalled pills to continue taking their medication; the reason, the agency has explained, is because the risk of uncontrolled high blood pressure is potentially far greater than the risk of exposure to trace amounts of this impurity.
Instead of stopping the medication, patients are advised to contact their doctor or pharmacist to see how to proceed, such as getting a prescription for a different medication before they stop taking the recalled product. The new recalled lots are:
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count, Batch No. 4DU2E009, Exp. 12/31/2020
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count, Batch No. 4DU3E009, Exp. 12/31/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count, Batch No. 4DU3D018, Exp. 02/28/2021
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count, Batch No. BEF7D051, Exp. 11/30/2020
13668-118-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count, Batch No. 4P04D007, Exp. 07/31/2020