RecallDepth
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 19124; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512.

This recall has been terminated (originally issued October 21, 2015).

Company
Tribute Pharmaceuticals Us Inc.
Recall Initiated
October 1, 2015
Posted
October 21, 2015
Recall Number
D-0016-2016
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
39,650 bottles
Firm Location
Charlotte, NC, United States
Official Source
View on FDA website ↗

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

Lot / Code Info

Lot #: 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

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