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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012
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Product Detail

Product Description Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.
Recall Number D-1382-2012
Classification Class II
Code Info Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
Product Distributed Qty a) 36,125 vials; b) 31,280 vials
Reason For Recall Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles.

Event Detail

Event Id 62009
Product Type Drugs
Status Ongoing
Recalling Firm Hospira, Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide.
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