Home / Recalls / Mutual Pharmaceutical Company, Inc. / D-398-2014

D-398-2014 Class III Terminated

Recalled by Mutual Pharmaceutical Company, Inc. — Philadelphia, PA

Recall Details

Product Type
Drugs
Report Date
January 15, 2014
Initiation Date
February 27, 2013
Termination Date
April 1, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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

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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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

Nationwide and Puerto Rico.

Code Information

Lots 6504705, 6504706 exp. 05/14

Other recalls by Mutual Pharmaceutical Company, Inc.

  • D-0572-2016 Class II — Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 1 (October 9, 2015)
  • D-1423-2015 Class III — Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual P (July 16, 2015)
  • D-1420-2015 Class III — Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual (July 16, 2015)
  • D-1425-2015 Class III — Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceut (July 16, 2015)
  • D-1421-2015 Class III — Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual (July 16, 2015)
  • D-1422-2015 Class III — Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual P (July 16, 2015)
  • D-1424-2015 Class III — Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceut (July 16, 2015)
  • D-1282-2015 Class II — Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, M (July 9, 2015)
  • D-1280-2015 Class II — Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 5348 (July 9, 2015)
  • D-1281-2015 Class II — Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 5348 (July 9, 2015)