Losartan Potassium and Hydrochlorothiazide Tablets recalled over manufacturing violations

Recall date

February 21, 2019

Source

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

Official notice title

Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macl…

Recall number

D-1040-2019

FDA classification

Class II

Brand / firm

Macleods Pharma Usa Inc

Sold / distributed

NJ, NY, FL

Why it was recalled

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

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 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10