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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65731
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and Guam

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20. Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01 Class II Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial. 268,700 vials D-813-2013