The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-398-2014·Announced 2014-01-15

Mutual Pharmaceutical Recalls FIBRICOR Tablets Due to Labeling Error

Mutual Pharmaceutical is recalling FIBRICOR (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 FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Mutual Pharmaceutical Company, Inc. is recalling FIBRICOR (fenofibric acid) Tablets, 105 mg, in 30-count and 90-count bottles. The recall involves lots 6504705 and 6504706 with an expiration date of 05/14. The product was distributed nationwide and in Puerto Rico.

The recall was initiated due to a labeling error in section 5.11 of the patient insert. The current text provides incorrect medical advice regarding 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 The correct instructions state that if a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, the HDL-C level monitored until it returns to baseline, and therapy should not be re-initiated.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 or pharmacist for guidance. The FDA has classified this as a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.

The recalled product

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
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)

  • Lots 6504705
  • 6504706 exp. 05/14

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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