FDAClass IDecember 28, 2016

Bupivacaine Hydrochloride Inj recall: Particulate Matter

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02

Why was Bupivacaine Hydrochloride Inj recalled?

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 # 59064DK, Exp. 11/17

Product
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Recalling firm
Hospira Inc., A Pfizer Company
Quantity
143,250 vials
Distribution
Nationwide
Recall date
December 28, 2016
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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