FDA Drug recall D-399-2014
Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC…
- FDA Drug
- Class III
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class III recall of Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC… by Mutual Pharmaceutical, citing 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 de….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-399-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-27 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mutual Pharmaceutical |
| Distribution | US |
Product
Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07
Reason
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
Identifiers
| code_info | Lot 6561703, exp. 03/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-399-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.