FDAFDA · Food and drugs·Recall number D-0163-2016
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
Published November 11, 2015 · Recall initiated: September 4, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Failed 24 month dissolution testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Distributor
- U.S. Nationwide
- Lot
- Lot # 1300939, Expiry: March 2016.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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