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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
Recall Number D-184-2013
Classification Class II
Code Info Lot # 10-199-JT Exp. 10/13
Product Distributed Qty 11,412 bags
Reason For Recall Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.

Event Detail

Event Id 63522
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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