Product: Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC  53489-677-07
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  Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
Recall initiated: 20130227
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated