FDA recall D-0727-2021

High Performance Formulas, L.L.C. (HPF, L.L.C.) · Class II · drug

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

Distribution

Product was distributed nationwide.

Key facts

Status: Terminated
Initiation date: 2021-07-26
Report date: 2021-08-25
Termination date: 2023-05-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Yardley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0727-2021