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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Category
- Drug — Injection
- Hazard
- 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.
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