Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 13310-102-90, UPC 3 13310-102-90 7; Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; and c) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 49708-102-07, UPC 3 49708 10207 5; d) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 49708-102-90, UPC 3 49708 10290 7; e) Fenofibric Acid Tablets, 30-count bottles, NDC 53489-678-07, UPC 3 53489 67807 0; f) Fenofibric Acid Tablets, 90-count bottles, NDC 53489-678-90, UPC 3 53489 67890 2; Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Distributed by: Sun Pharmaceutical Industries, Inc, Cranbury, NJ 08512; g) Fenofibric Acid Tablets, 30-count bottles, Professional Sample, NDC 53489-678-87, UPC 3 53489-678-87 2; Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA.
Drug Recall
Official source record
- Recall number
- D-0017-2016
- Event ID
- 72346
- Classification
- Class III
- Status
- Terminated
- Recalling company
- Tribute Pharmaceuticals US Inc.
- Reason for recall
- 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.
- Report date
- October 21, 2015
- Recall initiation date
- October 1, 2015
- Termination date
- October 27, 2017
- Distribution pattern
- Nationwide and Puerto Rico
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
