Losartan Potassium and Hydrochlorothiazide Tablets recalled over manufacturing violations

Recall date

June 20, 2019

Source

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

Official notice title

Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma…

Recall number

D-1459-2019

FDA classification

Class II

Brand / firm

Macleods Pharma Usa Inc

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

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 and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10