Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter
Hospira, Inc. is recalling 1% Lidocaine Hydrochloride Injection vials because oxidized stainless steel was found in the product.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 5 according to the rubric.
Plain-English summary
Hospira, Inc. is recalling 374,500 vials of 1% Lidocaine Hydrochloride Injection, USP (NDC 0409-4276-01). The recall was initiated due to the presence of particulate matter, specifically oxidized stainless steel, found in a vial of the product.
The affected product is identified by Lot #25090DK and has an expiration date of 01/15. The vials were distributed nationwide. The product is a human prescription drug intended for infiltration and perineural routes.
Consumers and healthcare providers should stop using the affected vials and contact their supplier or Hospira, Inc. for further instructions or a return.
The recalled product
- Product
- LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
- Brand
- LIDOCAINE HYDROCHLORIDE
- Manufacturer
- Hospira, Inc.
- Category
- Drug — Injection
- Affected units
- 374,500
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 #25090DK
- Exp 01/15
Distribution
Distributed nationwide across the United States.
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