The Recall Desk
SevereFDA (Drugs)·D-66201-001·Announced 2013-10-09

Hospira Recalls Lidocaine Ampuls Due to Visible Particulate Matter

Hospira is recalling 86,400 ampuls of 5% Lidocaine HCl and 7.5% Dextrose Injection due to reports of visible particulates in the glass ampules.

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 II, which corresponds to a 'Severe' rating under the rubric for significant injury or property damage reports, or high-risk contamination.

Plain-English summary

Hospira, Inc. is recalling 86,400 ampuls of 5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls. The specific lot affected is 23-227-DK, identified by NDC 0409-4712-01. The product is prescription-only and was distributed nationwide.

The recall was initiated due to reports of visible particulate matter present in the glass ampules. This particulate matter poses a potential risk to patients if the product is administered.

Healthcare providers and patients should stop using the affected lot immediately. Consumers should check their medication for the specific lot number and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
Manufacturer
Hospira Inc.
Affected units
86,400

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 (1)

  • Lot 23-227-DK

Distribution

Distributed nationwide across the United States.