FDAClass IIMarch 12, 2014

Bupivacaine HCl Inj. USP recall: Particulate Matter

Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02

Why was Bupivacaine HCl Inj. USP recalled?

Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.

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 25-097-DK; Exp 01/01/2015

Product
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02
Recalling firm
Hospira Inc.
Quantity
115,500 Vials
Distribution
Nationwide
Recall date
March 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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