# FDA recall D-398-2014

> **Mutual Pharmaceutical Company,  Inc.** · Class III · drug recall initiated 2013-02-27.

## 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

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  Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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

## Key facts

- **Recall number:** D-398-2014
- **Recalling firm:** Mutual Pharmaceutical Company,  Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-02-27
- **Report date:** 2014-01-15
- **Termination date:** 2014-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Philadelphia, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-398-2014

## Citation

> AI Analytics. FDA recall D-398-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-398-2014. Source: US FDA. Licensed CC0.

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