FDAClass IIJanuary 8, 2014

0.5% Bupivacaine HCl and Epinephrine 1:200 recall: Sterility Concern

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…

Why was 0.5% Bupivacaine HCl and Epinephrine 1:200 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Hospira Inc.
Quantity
65109 vials
Distribution
US Nationwide.
Recall date
January 8, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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