July 2021 FDA Recall Drug by High Performance Formulas, L.l.c. (hpf, L.l.c.) (D-0727-2021 - Marketed Without an Approved NDA/ANDA)

This Class II drug recall was voluntarily initiated by High Performance Formulas, L.l.c. (hpf, L.l.c.) on July 26, 2021 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0727-2021

Reason for Recall
Marketed Without an Approved NDA/ANDA
Initiated
07-26-2021
Reported
08-25-2021
Quantity
14,848 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88310
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
High Performance Formulas, L.L.C. (HPF, L.L.C.)
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-04-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 30317, exp. date 02/2026