FDA Drug Moderate Class II Terminated

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

Reported: August 25, 2021 Initiated: July 26, 2021 #D-0727-2021

Product Description

Reason for Recall

Marketed Without an Approved NDA/ANDA

Details

Recalling Firm: High Performance Formulas, L.L.C. (HPF, L.L.C.)
Units Affected: 14,848 bottles
Distribution: Product was distributed nationwide.
Location: Yardley, PA

Frequently Asked Questions

What product 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. Recalled by High Performance Formulas, L.L.C. (HPF, L.L.C.). Units affected: 14,848 bottles.

Why was this product recalled? ▼

Marketed Without an Approved NDA/ANDA

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 25, 2021. Severity: Moderate. Recall number: D-0727-2021.