Recall on medication used to treat hypertension expanded

Recall on medication used to treat hypertension expanded
(Source: ABC/NBC)

(WAFB) - The U.S. Food and Drug Administration (FDA) announced an expansion of a recall on medications used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy, and nephropathy in Type 2 diabetic patients.

The expanded recall includes an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP. Those products have been found to include N-Methylnitrosobutyric acid (NMBA), an impurity.

NDC Product Name, Strength and Package Count Batch Number Expiration Date
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E009 12/31/2020
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E009 12/31/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3D018 02/28/2021
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D051 11/30/2020
13668-118-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. 4P04D007 07/31/2020

Patients are asked to continue taking their medication until they are able to speak with a doctor who can recommend a replacement treatment plan. The risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

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