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U.S. Department of Health and Human Services

Enforcement Report - Week of October 29, 2014

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Product Detail

Product Description Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07
Recall Number D-0036-2015
Classification Class II
Code Info Lot A369286, exp. date 31 Jan 2016
Product Distributed Qty 94,584 cartons
Reason For Recall Failed Dissolution Specification; at the 6-month stability time point

Event Detail

Event Id 69298
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 2014-09-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide including Puerto Rico.