Drug 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.
D-0016-2016
Product summary
- Event
- Event 72346
- Status
- Terminated
- Classification
- Class III
- Quantity
- 39,650 bottles
- Official record key
drug-enforcement:D-0016-2016
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 #: 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
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination