Recalls / Class III

Class IIID-400-2014

Product

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

Affected lot / code info

lot 6581105 & 6581106 exp. 07/15, and lot 6623001 & 6623002 exp. 01/16

Why it was recalled

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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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

Recalling firm

Firm

Mutual Pharmaceutical Company, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1100 Orthodox St, Philadelphia, Pennsylvania 19124-3168

Distribution

Distribution pattern

Nationwide and Puerto Rico.

Timeline

Recall initiated

2013-02-27

FDA classified

2014-01-06

Posted by FDA

2014-01-15

Terminated

2014-04-01

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-400-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.