Novartis unit Sandoz has voluntarily recalled one lot of Losartan Potassium-Hydrochlorothiazide tablets after finding traces of impurity in the API Losartan manufactured by Zhejiang Huahai Pharmaceutical (ZHP).
The N-nitrosodiethylamine (NDEA) impurity is classified as a potential human carcinogen by the International Agency for Research on Cancer (IARC).
Losartan Potassium-Hydrochlorothiazide tablets are indicated for the treatment of hypertension as a monotherapy or in combination with other antihypertensive agents.
Sandoz said that the recalled lot of its products, which are produced by Lek Pharmaceuticals in Slovenia, has so far not led to any adverse event reports.
The company is notifying distributors and retailers and asking them to immediately cease distribution of the identified batch.
It also advised patients to seek alternative therapy before returning their current medication.
Sandoz in a statement said: “Patients who are on Losartan Potassium-Hydrochlorothiazide should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.
“Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Losartan Potassium-Hydrochlorothiazide.”
NDEA was previously discovered by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in September in multiple batches of drugs containing valsartan as the active pharmaceutical ingredient (API).
ZHP reported the presence of this impurity in several batches of its valsartan API. The FDA also found it in three lots of Torrent Pharmaceuticals’ recalled valsartan products.