Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter
Hospira is recalling specific vials of 1% Lidocaine Hydrochloride Injection because a returned sample contained human hair attached to the stopper.
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, as it represents a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Hospira Inc. is recalling 100,100 units of 1% Lidocaine Hydrochloride Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vials. The recall is limited to Lot# 40-316-DK with an expiration date of 01APR2016. The product is identified by NDC 0409-4279-02.
The recall was initiated after a returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper. This constitutes the presence of particulate matter in the product.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
- Brand
- LIDOCAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 100,100
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# 40-316-DK
- Exp 01APR2016
Distribution
Distributed nationwide across the United States.
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