D-0016-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 21, 2015
- Initiation Date
- October 1, 2015
- Termination Date
- October 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39,650 bottles
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
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