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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Recall Number D-176-2013
Classification Class II
Code Info Lot 13-121-JT* * the lot number may be followed by 01
Product Distributed Qty 56,854 Units
Reason For Recall Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.

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
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