The Recall Desk
SevereFDA (Drugs)·D-1278-2014·Announced 2014-05-07

Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter

Hospira Inc. is recalling Lidocaine Hydrochloride Injection due to confirmed particulate matter in the glass containers.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Hospira Inc. is recalling Lidocaine Hydrochloride Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials. The recall involves Lot 32135DD with an expiration date of 08/15. A total of 68,350 vials were distributed nationwide.

The recall was initiated following a confirmed customer complaint regarding the presence of particulate matter. The complaint specified that particulates were embedded in the glass container and in contact with the product solution.

Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or replacement.

The recalled product

Product
LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Brand
LIDOCAINE HYDROCHLORIDE
Manufacturer
Hospira Inc.
Affected units
68,350

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 32135DD
  • Exp 08/15

Distribution

Distributed nationwide across the United States.