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.
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 3
FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Incorrect instructions; an error
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Incorrect instructions; an error
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Code information
Lot 6561703, exp. 03/14
Distribution pattern
Nationwide and Puerto Rico.
drug · product 3 of 3
Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Incorrect instructions; an error
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Code information
lot 6581105 & 6581106 exp. 07/15, and lot 6623001 & 6623002 exp. 01/16
