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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 Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Recall Number D-309-2013
Classification Class II
Code Info Lot 17-100-EV and 17-399-EV
Product Distributed Qty 172,350 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