High Performance Formulas, L.L.C. (HPF, L.L.C.): Drug Recall

Recall #D-0727-2021 · 07/26/2021

Class II: Risk

Recall Details

Recall Number
D-0727-2021
Classification
Class II
Product Type
Drug
Recalling Firm
High Performance Formulas, L.L.C. (HPF, L.L.C.)
Status
Terminated
Date Initiated
07/26/2021
Location
Yardley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,848 bottles

Reason for Recall

Marketed Without an Approved NDA/ANDA

Product Description

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

Distribution Pattern

Product was distributed nationwide.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.