Class II
Terminated
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
This recall has been terminated (originally issued August 25, 2021).
- Recall Initiated
- July 26, 2021
- Posted
- August 25, 2021
- Recall Number
- D-0727-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,848 bottles
- Firm Location
- Yardley, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Marketed Without an Approved NDA/ANDA
Distribution
Product was distributed nationwide.
Lot / Code Info
Lot #30317, exp. date 02/2026
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