The Recall Desk
LowFDA (Drugs)·D-0016-2016·Announced 2015-10-21

Tribute Pharmaceuticals Recalls Fenofibric Acid Tablets Due to Benzophenone Contamination

Tribute Pharmaceuticals is recalling specific lots of Fenofibric Acid Tablets because they may contain trace amounts of benzophenone from label varnish.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which indicates a low risk of adverse health consequences. The hazard involves trace amounts of a chemical from label varnish, consistent with minor or documentation-level issues.

Plain-English summary

Tribute Pharmaceuticals US Inc. is recalling 39,650 bottles of Fenofibric Acid Tablets, 35 mg, 30-count. The affected products are labeled as FIBRICOR (fenofibric acid) Tablets or Fenofibric Acid Tablets and were distributed nationwide and in Puerto Rico.

The recall was initiated due to 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. The FDA has classified this recall as Class III.

Consumers with these specific products should stop using them and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement. The affected lot numbers and expiration dates are: a) 6631401 (Exp 03/16); b) 6631403 (Exp 03/16), 6697001 (Exp 06/17); c) 6631402 (Exp 03/16), 6663401 (Exp 10/16), 6697002, 6697004 (Exp 06/17).

The recalled product

Product
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: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; b) FIB
Manufacturer
Tribute Pharmaceuticals US Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
39,650

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Lot #: a) 6631401
  • Exp 03/16
  • b) 6631403
  • 6697001
  • Exp 06/17
  • c) 6631402
  • 6663401
  • Exp 10/16
  • 6697002
  • 6697004

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Tribute Pharmaceuticals US Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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