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Recall Observatory FDA recall evidence

Drug product

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

D-096-2013

November 21, 2012

Class II

Product summary

Firm
Hospira, Inc.
Event
Event 63884
Status
Terminated
Classification
Class II
Quantity
145,400 vials
Official record key
drug-enforcement:D-096-2013

Official wording

Reason: 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.

Code information: Lot #: 11-293-DK, Exp 05/01/13

Distribution pattern: Nationwide and Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility