Drug & medication recalls Moderate risk

Valeant Pharmaceuticals North America LLC recalls Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92…

Recall date
September 4, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0163-2016
FDA classification
Class II
Brand / firm
Valeant Pharmaceuticals North America LLC
Sold / distributed
U.S. Nationwide

Why it was recalled

Failed Dissolution Specifications: Failed 24 month dissolution testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.

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