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.
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 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.
- Category
- Drug — Injection
- 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.
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