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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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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
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot: A287945, Exp: 08/2015 Class II 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. 21,875 bottles D-1348-2014