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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30
Recall Number D-1348-2014
Classification Class II
Code Info Lot: A287945, Exp: 08/2015
Product Distributed Qty 21,875 bottles
Reason For Recall Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.

Event Detail

Event Id 68246
Product Type Drugs
Status Ongoing
Recalling Firm Forest Pharmaceuticals Inc
City Earth City
State MO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico