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.
Reported: January 8, 2014 Initiated: October 11, 2013 #D-395-2014
Product Description
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 for Recall
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 65109 vials
- Distribution
- US Nationwide.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira Inc.. Units affected: 65109 vials.
Why was this product recalled? ▼
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 8, 2014. Severity: Moderate. Recall number: D-395-2014.
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