The Recall Desk
CriticalFDA (Drugs)·D-1234-2014·Announced 2014-04-23

Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter

Hospira, Inc. is recalling 1% Lidocaine Hydrochloride Injection vials because oxidized stainless steel was found in the product.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 5 according to the rubric.

Plain-English summary

Hospira, Inc. is recalling 374,500 vials of 1% Lidocaine Hydrochloride Injection, USP (NDC 0409-4276-01). The recall was initiated due to the presence of particulate matter, specifically oxidized stainless steel, found in a vial of the product.

The affected product is identified by Lot #25090DK and has an expiration date of 01/15. The vials were distributed nationwide. The product is a human prescription drug intended for infiltration and perineural routes.

Consumers and healthcare providers should stop using the affected vials and contact their supplier or Hospira, Inc. for further instructions or a return.

The recalled product

Product
LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Brand
LIDOCAINE HYDROCHLORIDE
Manufacturer
Hospira, Inc.
Affected units
374,500

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 #25090DK
  • Exp 01/15

Distribution

Distributed nationwide across the United States.