Mutual Pharmaceutical Company, Inc. recalls Fenofibric Acid, immediate release tablet, 35 mg, 30 count b
Recalled 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
Hazard / Issue
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
Issued by
FDA
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