The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-400-2014·Announced 2014-01-15

Mutual Pharmaceutical Recalls Fenofibric Acid Tablets Due to Labeling Error

Mutual Pharmaceutical is recalling specific lots of Fenofibric Acid tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or labeling issues.

Plain-English summary

Mutual Pharmaceutical Company, Inc. is recalling specific lots of Fenofibric Acid, immediate release tablets, 105 mg. The affected products are available in 30-count and 90-count bottles and are distributed nationwide and in Puerto Rico. The specific lots involved are 6581105, 6581106, 6623001, and 6623002, with expiration dates of 07/15 and 01/16.

The recall is due to a labeling error in section 5.11 of the patient insert. The current text provides incorrect medical advice concerning the management of severely depressed HDL-C levels. The correct instructions state that if a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, the HDL-C level monitored until it returns to baseline, and therapy should not be re-initiated.

Consumers with these specific lots should contact their healthcare provider for guidance on the correct medical advice.

The recalled product

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
Manufacturer
Mutual Pharmaceutical Company, Inc.
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Mutual Pharmaceutical Company, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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