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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12
Recall Number D-927-2013
Classification Class II
Code Info Lot: 23-505-EV, Exp. 11/14
Product Distributed Qty 72,300 vials
Reason For Recall Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.

Event Detail

Event Id 66104
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico