Tribute Pharmaceuticals Recalls Fenofibric Acid Tablets Due to Benzophenone Contamination
Tribute Pharmaceuticals is recalling 140,607 bottles of Fenofibric Acid Tablets 105 mg 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Tribute Pharmaceuticals US Inc. is recalling 140,607 bottles of Fenofibric Acid Tablets 105 mg, prescription only. The affected products are labeled as FIBRICOR or generic Fenofibric Acid Tablets in 30-count and 90-count bottles, as well as professional samples. The recall covers specific lot numbers with expiration dates ranging from January 2016 to May 2017.
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 affected units were distributed nationwide and in Puerto Rico.
Consumers who have these specific bottles should stop using them and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class III, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- 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…
- Manufacturer
- Tribute Pharmaceuticals US Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 140,607
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 (20)
- Lot numbers: a) 6623102
- Exp 01/16
- b) 6623104
- c) 6674403
- Exp 01/17
- d) 6674402
- e) 6623001
- 6623004
- 6623103
- 6639202
- 6639203
- 6639303
- 6639304
- Exp 04/16
- 6674404
- 6693301
- Exp 05/17
- f) 6623002
- 6623005
- 6623105
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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