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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 64719
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-25
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA. a) Lot #: 06-804-DJ*, Exp 1JUN2013; and b) Lot #: 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02. Class II Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection. 68,020 vials D-223-2013