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
D-0727-2021
Product summary
- Event
- Event 88310
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,848 bottles
- Official record key
drug-enforcement:D-0727-2021
Official wording
Reason: Marketed Without an Approved NDA/ANDA
Code information: Lot #30317, exp. date 02/2026
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA