The Food and Drug Administration (FDA) is reiterating its warning to the public against the administration, sale, and consumption of the anti-hypertension drug product, Losartan Potassium + Hydrochlorothiazide 100mg/25mg Tablet, Director General Nela Charade G. Puno said.
The FDA particularly warns on the drug manufactured by Lek Pharmaceuticals dd, Ljubljana in Slovenia, on a particular batch/lot which is being voluntarily recalled by Sandoz Inc., per the recent public advisory released by the United States (US) FDA.
The Active Pharmaceutical Ingredient (API), Losartan, manufactured by Zhejiang Huahai Pharmaceuticals Co. Ltd. in Linhai, China, was reported to contain trace amount of the impurity, N-nitrosodiethylamine (NDEA).
The said impurity was classified as a probable human carcinogen as per the World Health Organization (WHO) International Agency for Research on Cancer (IARC). Such is the categorization due to limited evidence of carcinogenicity in humans.
Losartan Potassium + Hydrochlorothiazide is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.
Although limited to a certain batch/lot (Lot No. JB8912), the FDA is currently monitoring the subject drug product through heightened Post Marketing Surveillance (PMS) operations. It is coordinating with its Market Authorization Holder or MAH for its immediate recall in the Philippines, pending confirmation of their safety for public consumption.
Puno warns retail drug outlets, and other dealers of pharmaceutical products against the sale of this affected lot of Losartan + Hydrochlorothiazide 100mg/25mg Tablet.
FDA initially issued the warning last November 2018 but reitrated the advisory again because of the proliferation of tainted Losartan in the market.
“For everyone’s protection, I am calling on the public to report the sale or distribution of the subject drug product despite the issuance of this Advisory. Kindly email us via [email protected].,” Puno requested.
For more information and inquiries, please e-mail [email protected] or call the FDA Action Center hotline (02) 821-1162.