The Recall Desk
SevereFDA (Drugs)·D-0020-2015·Announced 2014-10-22

Hospira Recalls Lidocaine Hydrochloride Vials Due to Particulate Matter

Hospira is recalling 109,110 vials of Lidocaine Hydrochloride Injection because the product was discolored and contained visible particulates.

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 recall is classified as FDA Class I, which meets the rubric criteria for a score of 4 (Severe) as it is a serious health hazard.

Plain-English summary

Hospira, Inc. is recalling 109,110 vials of Lidocaine Hydrochloride Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial. The affected product is identified by Lot Number 25-550-DD and an expiration date of January 2015. The recall covers vials distributed nationwide.

The recall was initiated because the product was found to be discolored and contained visible particulates, specifically iron oxide, in the solution and embedded in the glass vial. The product is a prescription-only medication intended for infiltration and nerve block, including epidural and caudal administration.

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
109,110

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 Number: 25-550-DD
  • Exp: 1JAN2015

Distribution

Distributed nationwide across the United States.