Another Blood Pressure Drug Recalled Under Carcinogen Scare

Sandoz is recalling a single lot of losartan potassium and hydrochlorothiazide 100 mg/25 mg tablets because the product was made with an active pharmaceutical ingredient (API) that has tested positive for trace amounts of the probable carcinogen N-Nitrosodiethylamine or NDEA. Over the summer, a multitude of lots of drugs containing valsartan were recalled by various companies for the same reason.

The latest NDEA-related recall was announced by the US Food and Drug Administration in a November 9, 2018, statement. The API under scrutiny was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd.

The voluntary recall affects losartan potassium and hydrochlorothiazide 100 mg/25 mg tablets in 1000-count bottles (NDC 0781-5207-10) from lot JB8912 (Exp. 6/20). The tablets were distributed throughout the United States after October 8, 2018.

“To date, Sandoz Inc. has not received any reports of adverse events related to this lot,” the company announced in a November 8, 2018, press release.

Losartan potassium hydrochlorothiazide is an angiotensin II receptor blocker indicated, alone or in combination with other drugs, for the treatment of hypertension.

According to the FDA, Sandoz’s losartan products constitute less than 1% of all losartan medications in the United States.

—Jolynn Tumolo

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