Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lak...
FDA Recall #D-096-2013 — Class II — November 21, 2012
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
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.
Recalling Firm
Hospira, Inc. — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
145,400 vials
Distribution
Nationwide and Puerto Rico.
Code Information
Lot #: 11-293-DK, Exp 05/01/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated