Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.
Reported: November 11, 2015 Initiated: September 4, 2015 #D-0163-2016
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.
Details
- Recalling Firm
- Valeant Pharmaceuticals North America LLC
- Units Affected
- 3341 Bottles
- Distribution
- U.S. Nationwide
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.. Recalled by Valeant Pharmaceuticals North America LLC. Units affected: 3341 Bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Failed 24 month dissolution testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 11, 2015. Severity: Moderate. Recall number: D-0163-2016.
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