FDAClass IISeptember 24, 2014

Bupivacaine HCl Inj recall: Particulate Matter

Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal…

Why was Bupivacaine HCl Inj recalled?

Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of 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 37-268-DK; Exp: 1JAN2016

Product
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal…
Recalling firm
Hospira Inc.
Quantity
75,000 vials
Distribution
Nationwide
Recall date
September 24, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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