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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Detail

Product Description Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
Recall Number D-308-2013
Classification Class II
Code Info Lot 15-065-DK, Exp 1SEP2013
Product Distributed Qty 26,100 vials
Reason For Recall Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial

Event Detail

Event Id 64720
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico