FDAFDA · Food and drugs·Recall number D-395-2014
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.
Published January 8, 2014 · Recall initiated: October 11, 2013
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; equipment failure led to potential breach in asceptic process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Distributor
- US Nationwide.
- Lot
- Lot #32-484-EV, 32-485-EV Exp: 2/2015.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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