Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet recalled over manufacturing violations

Recall date

August 20, 2018

Source

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

Official notice title

RemedyRepack Inc. recalls Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD…

Recall number

D-1146-2018

FDA classification

Class II

Brand / firm

RemedyRepack Inc.

Sold / distributed

South Carolina

Why it was recalled

CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical 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

Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0