Two lots of Torrent Pharmaceuticals Limited’s Losartan potassium tablets are the latest heart drugs to be recalled due to the presence of a probable human carcinogen called N-nitrosodiethylamine (NDEA).
Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and for the treatment of nephropathy in type 2 diabetic patients. Patients currently taking Losartan should continue taking the medication because the risk of harm may be greater if the treatment is stopped abruptly without an alternative medication. Patients should contact their pharmacist or physician with concerns.
Torrent’s recalled Losartan potassium tablets include
- Losartan Potassium Tab, USP, 100mg, 30-count bottles, NDC 13668-115-30, Lot BO31C016, Expiration date 04/2019
- Losartan Potassium Tab, USP, 100mg, 90-count bottles, NDC 13668-115-90, Lot BO31C016, Expiration date 04/2019
- Losartan Potassium Tab, USP, 100mg, 1000-count bottles, NDC 13668-115-10, Lot 4DK3C005, Expiration date 04/2019
Lorsartan is in a class of drugs called angiotensin II receptor blockers, or ARBs, which are used to treat high blood pressure and heart failure. In July, the Food and Drug Administration announced a recall of another ARB, Valsartan, due to the presence of NDEA. Since then, several ARBs – including Valsartan, Lorsartan and Irbesartan – have been recalled due to the presence of NDEA. The FDA has an ongoing investigation into ARBs and whether they contain carcinogenic impurities.
The agency has posted a list of recalled valsartan products, valsartan products currently not under recall and recalled irbesartan products, and continues to investigate the issue with ARBs. Patients, health care providers and pharmacists can call the FDA’s Division of Drug Information with any questions regarding the ARB recalls at 855-543-3784.
The FDA advised patients taking any of the recalled ARBs to continue to take their medication until their pharmacist or doctor can provide a replacement.
FDA Recall Notice