FDA (Drugs) recall action 64727
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
The agency’s own wording, quoted from the enforcement report.
Mutual Pharmaceutical is recalling specific lots of Fenofibric Acid tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.
Mutual Pharmaceutical is recalling FIBRICOR (fenofibric acid) tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.
Mutual Pharmaceutical is recalling specific lots of Fenofibric Acid tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.