FDA recall D-0163-2016
Valeant Pharmaceuticals North America LLC · Class II · drug
Product
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
U.S. Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2015-09-04
- Report date
- 2015-11-11
- Termination date
- 2017-03-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Bridgewater, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2016