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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Recall Number D-66637-001
Classification Class II
Code Info Lot #: 27-570-DJ, Exp 03/01/15
Product Distributed Qty 70,450 vials
Reason For Recall Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.

Event Detail

Event Id 66637
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide