drugs Class III Updated 2014-01-15

Mutual Pharmaceutical Company, Inc. recalls FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bott

Recalled Product

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


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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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

Distribution: Nationwide (United States)
Lot/Code Info: Lots 6504705, 6504706 exp. 05/14
View official government recall

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