Reported Oct 21, 2015 · Terminated
Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07,…
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?
Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for
5 of 5 products
| # | Product as published |
|---|---|
| 1 | AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA |
| 2 | by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA |
| 3 | FIBRICOR (fenofibric acid) Tablets, NDC 49708-101-07, UPC 3 49708 10107 8 |
| 4 | Fenofibric Acid Tablets, NDC 53489-677-07, UPC 3 53489 67707 3, Rx only, Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124 |
| 5 | Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. |
- Lot codes and dates
Lot #: a) 6631401Exp 03/16b) 6631403Exp 03/166697001Exp 06/17c) 6631402Exp 03/166663401Exp 10/1666970026697004Exp 06/17
- Amount recalled
- 39,650 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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