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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Event Detail

Event ID 66435
Product Type Drugs
Status Ongoing
Recalling Firm Hospira, Inc.
City Lake Forest
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-16
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA. Lot #17368EV Exp 08/13 Class II Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck. 29,700 vials D-023-2014