CLASS III Drug recall · Reported 15 Jan 2014 · FDA Enforcement Report
Fibricor (fenofibric acid) Tablets, 105 mg, a) bottle recalled
Mutual Pharmaceutical is recalling Fibricor (fenofibric acid) Tablets, 105 mg, a) bottle (, distributed nationwide in the US. The recall was initiated on 27 Feb 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-398-2014
- FDA event ID
- 64727
- Recalling firm
- Mutual Pharmaceutical, Philadelphia, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Feb 2013
- FDA classified
- 6 Jan 2014
- Reported
- 15 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 27 Feb 2013 | Recall initiated by company | |
| 6 Jan 2014 | Classified by FDA | +313 days |
| 15 Jan 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it 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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
Which lots are affected?
Lots 6504705, 6504706 exp. 05/14
Where was it sold?
Nationwide and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 64727This product is part of a recall event; the main page for the event is Fenofibric Acid, immediate release tablet, 105 mg, a) bottle recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Fenofibric Acid, immediate release tablet, 105 mg, a) bottle recalled | Mutual Pharmaceutical | Other | Nationwide | |
| CLASS III | Fenofibric Acid, immediate release tablet, 35 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
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|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets recalled | Mutual Pharmaceutical | Other | MS |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 10 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 25 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 50 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Felodipine Extended-Release Tablets, 5 mg recalled | Mutual Pharmaceutical | Other | Nationwide |