Exact FDA event identifier

Event 68638

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

Event summary

Timeline bucket: June 24, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Doctor's Best, Inc.

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

Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673

D-1549-2014

Recall number: D-1549-2014
Initiated: June 24, 2014
Classification: Class II
Status: Terminated
Recalling firm: Doctor's Best, Inc.
Quantity: 7,379 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.

Code information

Lot # 3121005; Exp 02/17

Distribution pattern

Nationwide