Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter
Hospira Inc. is recalling 120,900 vials of 1% Lidocaine Hydrochloride Injection because iron oxide particulates were found in the solution.
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 according to the rubric, as it represents a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Hospira Inc. is recalling 120,900 vials of 1% Lidocaine Hydrochloride Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials. The affected product is packaged in 25-count cartons and is available by prescription only. The specific lot number is 31-427-DK with an expiration date of 01JUL2015.
The recall was initiated after a confirmed customer complaint identified orange and black particulates, which were identified as iron oxide, embedded within the glass vial and floating in the solution. This particulate matter presents a potential safety risk for patients receiving the injection.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled vials and contact their pharmacist or physician for guidance on alternative treatments or returns.
The recalled product
- Product
- LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
- Brand
- LIDOCAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 120,900
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: 31-427-DK
- Exp 01JUL2015.
Distribution
Distributed nationwide across the United States.
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