# FDA recall D-0016-2016

> **Tribute Pharmaceuticals US Inc.** · Class III · drug recall initiated 2015-10-01.

## 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) FIBRICOR (fenofibric acid) Tablets, NDC 49708-101-07, UPC 3 49708 10107 8; c) Fenofibric Acid Tablets, NDC 53489-677-07, UPC 3 53489 67707 3, Rx only, Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512.

## Reason for recall

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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0016-2016
- **Recalling firm:** Tribute Pharmaceuticals US Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-10-01
- **Report date:** 2015-10-21
- **Termination date:** 2017-10-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Charlotte, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0016-2016

## Citation

> AI Analytics. FDA recall D-0016-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0016-2016. Source: US FDA. Licensed CC0.

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