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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 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, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Recall Number D-297-2013
Classification Class II
Code Info Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02
Product Distributed Qty 245,250 vials
Reason For Recall Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.

Event Detail

Event Id 64990
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico