PlainRecalls
FDA Drug Low Class III Terminated

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 19

Reported: October 21, 2015 Initiated: October 1, 2015 #D-0016-2016

Product Description

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.

Details

Units Affected
39,650 bottles
Distribution
Nationwide and Puerto Rico
Location
Charlotte, NC

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Tribute Pharmaceuticals US Inc.. Units affected: 39,650 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 21, 2015. Severity: Low. Recall number: D-0016-2016.

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