Sandoz Losartan Potassium and Hydrochlorothiazide Tablets recalled over manufacturing violations

Recall date

November 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sandoz, Inc recalls Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug…

Recall number

D-0359-2019

FDA classification

Class II

Brand / firm

Sandoz, Inc

Sold / distributed

OH, PR

Why it was recalled

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.