Losartan Potassium Tablets recalled over manufacturing violations

Recall date

January 10, 2019

Source

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

Official notice title

MAJOR PHARMACEUTICALS recalls Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major…

Recall number

D-1466-2019

FDA classification

Class II

Brand / firm

MAJOR PHARMACEUTICALS

Sold / distributed

Nationwide.

Why it was recalled

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

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

What was recalled

Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.