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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 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.
- Category
- Drug — Injection
- Hazard
- 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.
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