Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #30317, exp. date 02/2026
Where it was sold
Product was distributed nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0727-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 26, 2021
- FDA report date
- Aug 25, 2021
- Quantity
- 14,848 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- High Performance Formulas, L.L.C. (HPF, L.L.C.)
Original FDA data
Every field from FDA enforcement report D-0727-2021, exactly as published.
Show all FDA fields
- City
- Yardley
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 88310
- Address
- 2001 Makefield Rd
- Code information
- Lot #30317, exp. date 02/2026
- Postal code
- 19067-3127
- Report date
- Aug 25, 2021
- Product type
- Drugs
- Recall number
- D-0727-2021
- Classification
- Class II
- Recalling firm
- High Performance Formulas, L.L.C. (HPF, L.L.C.)
- Product quantity
- 14,848 bottles
- Termination date
- May 4, 2023
- Reason for recall
- Marketed Without an Approved NDA/ANDA
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Jul 26, 2021
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 15, 2021