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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Recall Number D-502-2013
Classification Class II
Code Info Lot 11-309-KL
Product Distributed Qty 44,748 bags
Reason For Recall Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.

Event Detail

Event Id 65225
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico