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FDAFDA · Food and drugs·Recall number D-096-2013

Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01

Published December 26, 2012 · Recall initiated: November 21, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
NALBUPHINE HYDROCHLORIDE
Manufacturer
Hospira, Inc.
Distributor
Nationwide and Puerto Rico.
Lot
Lot #: 11-293-DK, Exp 05/01/13
Risk classification
Class II
Area (FDA)
drug
Country
United States

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