FDA-Drug2021-08-25Class II

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

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

Marketed Without an Approved NDA/ANDA

Sold states
Product was distributed nationwide.
Affected count
14,848 bottles
Manufactured in
2001 Makefield Rd, N/A, Yardley, PA, United States
Products
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

Official notice

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

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