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U.S. Department of Health and Human Services

Enforcement Report - Week of January 8, 2014

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Product Detail

Product Description 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
Recall Number D-395-2014
Classification Class II
Code Info Lot #32-484-EV, 32-485-EV Exp: 2/2015.
Product Distributed Qty 65109 vials
Reason For Recall Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.

Event Detail

Event Id 67045
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide.
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