D-0163-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 11, 2015
- Initiation Date
- September 4, 2015
- Termination Date
- March 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3341 Bottles
Product Description
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
Reason for Recall
Failed Dissolution Specifications: Failed 24 month dissolution testing.
Distribution Pattern
U.S. Nationwide
Code Information
Lot # 1300939, Expiry: March 2016.