Torrent Pharmaceuticals Recalls Losartan

December 20, 2018 – Drug manufacturer Torrent Pharmaceuticals has voluntarily recalled two lots of Losartan Potassium Tablets due to the presence of N-nitrosodiethylamine (NDEA). NDEA is considered a probable human carcinogen, and has been detected in other “sartan” products during the latter half of 2018.

Losartan and other "sartan" products belong to the angiotensin II receptor blocker (ARB) drug class and share some similarities in manufacturing processes. Previous recalls due to the presence of NDEA have included valsartan- and irbesartan-containing products, as well as losartan-containing products. NDEA is considered a probable human carcinogen (cancer-causing agent), and occurs naturally in certain foods, drinking water, air pollution, and industrial processes.

The FDA has reminded patients that they should not stop taking their recalled ARB medications without first consulting with a physician or pharmacist, or receiving a replacement product. Stopping treatment with an ARB without an appropriate replacement therapy can put patients at risk for serious harm that outweighs the potential for harm caused by small amounts of NDEA.

Consumers can contact Torrent at 1-800-912-9561 or Medinfo.Torrent@apcerls.com with questions or to report an adverse event that may be tied to the recalled medication. General questions about the return of the product should be directed to Qualanex at 1-888-280-2040. If patients experience an adverse event, they should notify their physician, and may also file a report with the FDA’s MedWatch program.

Further information regarding the recall, including affected lot numbers, can be found at: https://www.fda.gov/Safety/Recalls/ucm628966.htm
Global Reach RX was not affected by the recall.