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

Recall date

August 24, 2018

Source

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

Official notice title

RemedyRepack Inc. recalls Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30…

Recall number

D-0093-2019

FDA classification

Class II

Brand / firm

RemedyRepack Inc.

Sold / distributed

Product was distributed to a medical facility in 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 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00