Product: 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
Reason for recall: Marketed Without an Approved NDA/ANDA
Recall initiated: 20210726
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated