Cholestene capsules recalled over mold contamination

Recall date

July 26, 2021

Source

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

Official notice title

High Performance Formulas, L.L.C. (HPF, L.L.C.) recalls Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Form…

Recall number

D-0727-2021

FDA classification

Class II

Brand / firm

High Performance Formulas, L.L.C. (HPF, L.L.C.)

Sold / distributed

Product was distributed nationwide.

Why it was recalled

Marketed Without an Approved NDA/ANDA

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

What was recalled

Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4