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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
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