Torrent Pharmaceuticals Expands Losartan Recall
January 22, 2019 – Torrent Pharmaceuticals has expanded a recall of Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide (HCTZ) tablets to include 15 additional lots. The affected medications contain trace amounts of N-Nitrosodiethylamine (NDEA) in excess of the FDA’s currently established limits.
NDEA, which is considered a probable human carcinogen (cancer-causing agent) has been found in a number of “sartan” products, also known as angiotensin II receptor blockers (ARBs), since mid-2018. Similar recalls have affected products containing irbesartan and valsartan.
According to the FDA, patients who may be taking a recalled ARB should continue taking the medication until they receive a replacement product or have worked with their healthcare provider or pharmacist to switch to an alternative therapy. Stopping treatment with an ARB may put patients at higher risk of health complications than continued exposure to the NDEA found in the recalled medication.
Patients can contact Torrent Pharmaceuticals with medical questions related to the recall at 1-800-912-9561 or Medinfo.Torrent@apcerls.com. Any adverse events that may be tied to the recalled medication should be reported to the patient’s healthcare provider. These events can also be reported to the FDA’s MedWatch program.
For general questions about returning the recalled medication, patients should contact Qualanex at 1-888-280-2040. Additional details can be found at:
- Losartan Potassium Tablets: https://www.fda.gov/Safety/Recalls/ucm629261.htm
- Losartan/HCTZ Tablets: https://www.fda.gov/Safety/Recalls/ucm629693.htm
Benecard Central Fill was not impacted by this recall.