Drug 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, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; and c) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 49708-102-07, UPC 3 49708 10207 5; d) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 49708-102-90, UPC 3 49708 10290 7; e) Fenofibric Acid Tablets, 30-count bottles, NDC 53489-678-07, UPC 3 53489 67807 0; f) Fenofibric Acid Tablets, 90-count bottles, NDC 53489-678-90, UPC 3 53489 67890 2; Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Distributed by: Sun Pharmaceutical Industries, Inc, Cranbury, NJ 08512; g) Fenofibric Acid Tablets, 30-count bottles, Professional Sample, NDC 53489-678-87, UPC 3 53489-678-87 2; Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA.
D-0017-2016
Product summary
- Event
- Event 72346
- Status
- Terminated
- Classification
- Class III
- Quantity
- 140,607 bottles
- Official record key
drug-enforcement:D-0017-2016
Official wording
Reason: 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.
Code information: Lot numbers: a) 6623102, Exp 01/16; b) 6623104, Exp 01/16; c) 6674403, Exp 01/17; d) 6674402, Exp 01/17; e) 6623001, 6623004, 6623103, Exp 01/16; 6639202, 6639203, 6639303, 6639304, Exp 04/16; 6674404, Exp 01/17; 6693301, Exp 05/17; f) 6623002, 6623005, 6623105, Exp 01/16; 6639301, 6639305, Exp 04/16; 6674401, Exp 01/17; 6693302, Exp 05/17; g) 6623003, 6623106, Exp 01/16; 6639201, Exp 04/16.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination