Agency classClass IIOur severity:High FDA (Drugs)·D-1815-2015·Announced 2015-09-30

Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter

Hospira, Inc. is recalling Lidocaine Hydrochloride Injection vials because iron oxide particulate matter was found embedded in the glass vial necks.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the presence of particulate matter in an injectable drug represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Hospira, Inc. is recalling 100,200 vials of 1% Lidocaine Hydrochloride Injection, USP. The affected product is a single-dose, preservative-free 30 mL vial (NDC 0409-4279-02) distributed nationwide. The specific lot number is 44-359-DK, with an expiration date of 08/01/2016.

The recall was initiated because particulate matter, identified as iron oxide, was found embedded in the neck of the glass vials. This physical defect presents a risk of introducing foreign material into the patient during administration.

Healthcare providers and patients should discontinue use of the affected vials. The product is a prescription-only medication intended for infiltration or perineural routes. Users should check their inventory for the specific lot number and expiration date listed above.

The recalled product

Product: LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Brand: LIDOCAINE HYDROCHLORIDE
Manufacturer: Hospira, Inc.
Category: Drug — Injectable
Hazard: particulate-matter
foreign-object
Affected units: 100,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: 44-359-DK
Exp 08/01/2016

Distribution

Distributed nationwide across the United States.

Same brand · LIDOCAINE HYDROCHLORIDE

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