Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formu
Summary
The FDA issued a Class II for Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, by High Performance Formulas, L.L.C. (HPF, L.L.C.). Reason: Marketed Without an Approved NDA/ANDA.
Details
Source
Drug Recall
External ID
D-0727-2021
Action Date
2021-08-25
Status
Terminated
Category
drug
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/Code Info: Lot #30317, exp. date 02/2026
Quantity Affected: 14,848 bottles
Reason for Recall
Marketed Without an Approved NDA/ANDA
Distribution
Product was distributed nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-26
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (High Performance Formulas, L.L.C. (HPF, L.L.C.)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does High Performance Formulas, L.L.C. (HPF, L.L.C.) have FDA actions?
This is the only FDA action we have on record for High Performance Formulas, L.L.C. (HPF, L.L.C.) in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0727-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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