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U.S. Department of Health and Human Services

Enforcement Report - Week of June 10, 2015

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Product Detail

Product Description Zebeta® (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01
Recall Number D-1112-2015
Classification Class II
Code Info Lot #: 34019710A, Exp 5/2017
Product Distributed Qty 889 bottles
Reason For Recall Failed Dissolution Specifications: OOS result during stability testing

Event Detail

Event Id 71316
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA
City Horsham
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-05-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide