FDAClass IJuly 15, 2015

Bupivacaine Hydrochloride Inj recall: Particulate Matter

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA.…

Why was Bupivacaine Hydrochloride Inj recalled?

Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

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 #: 38-515-DK, Expiry: 1 FEB 2016.

Product
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA.…
Recalling firm
Hospira Inc.
Quantity
150,950 Vials
Distribution
U.S. Nationwide including Guam.
Recall date
July 15, 2015
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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