Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and…
Reason Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and…
Reason Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the…
Reason Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the…
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