Exact FDA event identifier

Event 88310

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: July 26, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: High Performance Formulas, L.L.C. (HPF, L.L.C.)

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0727-2021

Recall number: D-0727-2021
Initiated: July 26, 2021
Classification: Class II
Status: Terminated
Recalling firm: High Performance Formulas, L.L.C. (HPF, L.L.C.)
Quantity: 14,848 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed Without an Approved NDA/ANDA

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA

Code information

Lot #30317, exp. date 02/2026

Distribution pattern

Product was distributed nationwide.