Why it was 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.
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0016-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 1, 2015
- FDA report date
- Oct 21, 2015
- Quantity
- 39,650 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tribute Pharmaceuticals US Inc.
Original FDA data
Every field from FDA enforcement report D-0016-2016, exactly as published.
Show all FDA fields
- City
- Charlotte
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 72346
- Address
- 2015 Ayrsley Town BLVD
- 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
- Postal code
- 28273
- Report date
- Oct 21, 2015
- Product type
- Drugs
- Recall number
- D-0016-2016
- Classification
- Class III
- Recalling firm
- Tribute Pharmaceuticals US Inc.
- Product quantity
- 39,650 bottles
- Termination date
- Oct 27, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Oct 1, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 14, 2015