D-0727-2021 Class II Terminated
FDA drug recall D-0727-2021 was initiated by High Performance Formulas, L.L.C. (HPF, L.L.C.) on July 26, 2021 and is designated Class II. Reason for recall: Marketed Without an Approved NDA/ANDA The recall status is terminated (terminated May 4, 2023). Affected quantity: 14,848 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 25, 2021
- Initiation Date
- July 26, 2021
- Termination Date
- May 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,848 bottles
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
Reason for Recall
Marketed Without an Approved NDA/ANDA
Distribution Pattern
Product was distributed nationwide.
Code Information
Lot #30317, exp. date 02/2026