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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2012

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Product Detail

Product Description Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
Recall Number D-096-2013
Classification Class II
Code Info Lot #: 11-293-DK, Exp 05/01/13
Product Distributed Qty 145,400 vials
Reason For Recall Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.

Event Detail

Event Id 63884
Product Type Drugs
Status Ongoing
Recalling Firm Hospira, Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico.