Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter
Hospira is recalling Lidocaine Hydrochloride Injection vials because visible particulate matter embedded in the glass wall may dislodge into the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 source text explicitly identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe).
Plain-English summary
Hospira, Inc. is recalling Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vials. The recall affects 120,350 vials distributed nationwide. The specific lot number is 14-277-DK* (which may be followed by 01) with an expiration date of 02/01/14. The NDC for the affected product is 0409-4279-02.
The recall was initiated due to a report of a vial containing visible particulate matter embedded in the glass wall. There is a potential for this particulate matter to dislodge, resulting in the presence of particulate matter in the product.
This is a Class II recall, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above and discontinue use if found.
The recalled product
- Product
- LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
- Brand
- LIDOCAINE HYDROCHLORIDE
- Manufacturer
- Hospira, Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 120,350
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 (3)
- Lot #: 14-277-DK*
- Exp 02/01/14
- * may be followed by 01
Distribution
Distributed nationwide across the United States.
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