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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description 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.
Recall Number D-813-2013
Classification Class II
Code Info Lot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01
Product Distributed Qty 268,700 vials
Reason For Recall 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.

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 Letter
Distribution Pattern Nationwide and Guam