Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Mutual Pharmaceutical | Location not on file | Makes it and tests it | Not inspected on record |
| Mutual Pharmaceutical Company, Inc. | Location not on file | Makes it, packages it and labels it | Not inspected on record |
Recalls
- Oct 1, 2015 · Class III · Tribute Pharmaceuticals US Inc.
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Lots: Lot numbers: a) 6623102, Exp 01/16; b) 6623104, Exp 01/16; c) 6674403, Exp 01/17; d) 6674402, Exp 01/17; e) 6623001, 6623004, 6623103, Exp 01/16; 6639202, 6639203, 6639303, 6639304, Exp 04/16; 6674404, Exp 01/17; 6693301, Exp 05/17; f) 6623002, 6623005, 6623105, Exp 01/16; 6639301, 6639305, Exp 04/… - Feb 27, 2013 · Class III · Mutual Pharmaceutical Company, Inc.
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
Lots: Lots 6504705, 6504706 exp. 05/14
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fenofibric Acid: every company that makes it
- Form
- tablet
- Strength
- 105 mg
- Approval
- NDA NDA022418
- On the market since
- Aug 14, 2009
- Package NDCs
13310-102-0113310-102-0313310-102-0513310-102-0613310-102-0713310-102-1013310-102-90- Official label
- DailyMed (National Library of Medicine), updated Mar 19, 2013
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