Class III
Terminated
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
This recall has been terminated (originally issued January 15, 2014).
- Recall Initiated
- February 27, 2013
- Posted
- January 15, 2014
- Recall Number
- D-400-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Philadelphia, PA, United States
- Official Source
- View on FDA website ↗
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
Distribution
Nationwide and Puerto Rico.
Lot / Code Info
lot 6581105 & 6581106 exp. 07/15, and lot 6623001 & 6623002 exp. 01/16
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