Recall: D-395-2014
Class II - Potentially Harmful
Class IIClassification
2013-10-11Initiated
TerminatedStatus
Hospira Inc.Firm
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.
Reason
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Distribution
US Nationwide.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.