D-0163-2016 Class II Terminated

Recalled by Valeant Pharmaceuticals North America LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
November 11, 2015
Initiation Date
September 4, 2015
Termination Date
March 14, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3341 Bottles

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.

Distribution Pattern

U.S. Nationwide

Code Information

Lot # 1300939, Expiry: March 2016.