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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04
Recall Number D-314-2013
Classification Class II
Code Info Lot 20-564-DK Exp. 02/14
Product Distributed Qty 259,050 vials
Reason For Recall Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Event Detail

Event Id 65077
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico