Reported Oct 21, 2015 · Terminated
Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC…
Tribute Pharmaceuticals US Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tribute Pharmaceuticals US Inc. · 2015 Ayrsley Town BLVD · Charlotte, NC · 28273
Is this the product you have?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5 |
| 2 | 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 |
| 3 | FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 49708-102-07, UPC 3 49708 10207 5 |
| 4 | FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 49708-102-90, UPC 3 49708 10290 7 |
| 5 | Fenofibric Acid Tablets, 30-count bottles, NDC 53489-678-07, UPC 3 53489 67807 0 |
| 6 | 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 |
| 7 | 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. |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 6623102, Exp 01/16 2 6623104, Exp 01/16 3 6674403, Exp 01/17 4 6674402, Exp 01/17 5 6623001, 6623004, 6623103, Exp 01/16; 6639202, 6639203, 6639303, 6639304, Exp 04/16; 6674404, Exp 01/17; 6693301, Exp 05/17 6 6623002, 6623005, 6623105, Exp 01/16; 6639301, 6639305, Exp 04/16; 6674401, Exp 01/17; 6693302, Exp 05/17 7 6623003, 6623106, Exp 01/16; 6639201, Exp 04/16. - Amount recalled
- 140,607 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Tribute Pharmaceuticals US Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.