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Recall Observatory FDA recall evidence

Drug product

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.

D-395-2014

October 11, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 67045
Status
Terminated
Classification
Class II
Quantity
65109 vials
Official record key
drug-enforcement:D-395-2014

Official wording

Reason: Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.

Code information: Lot #32-484-EV, 32-485-EV Exp: 2/2015.

Distribution pattern: US Nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility