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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 64441
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-12
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
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08 Lot 13-121-JT* * the lot number may be followed by 01 Class II Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container. 56,854 Units D-176-2013
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