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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64083
Product Type Drugs
Status Ongoing
Recalling Firm Hospira, Inc.
City Rocky Mount
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04 18-099-DK Class II Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial 63,900 vials D-169-2013
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