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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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)…
- 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
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 →Related recalls
Same manufacturer · Tribute Pharmaceuticals US Inc.
See all →- LowTribute Pharmaceuticals Recalls Fenofibric Acid Tablets Due to Benzophenone Contamination
FDA (Drugs) · 2015-10-21
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