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U.S. Department of Health and Human Services

Enforcement Report - Week of October 16, 2013

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Event Detail

Event ID 66295
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-05
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide and Guam and Abu Dhabi

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045 Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01 Class II Lack of Assurance of Sterility; potential for vial breakage 187,150 vials D-66295-001
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