FDA-Drug2015-11-11Class II

Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.

Valeant Pharmaceuticals North America LLC
Hazard

Failed Dissolution Specifications: Failed 24 month dissolution testing.

Sold states
U.S. Nationwide
Affected count
3341 Bottles
Manufactured in
400 Somerset Corporate Blvd, N/A, Bridgewater, NJ, United States
Products
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC: 68012-495-90.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2016

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