Hospira Recalls Marcaine Injection Vials Due to Metal Particulate Matter
Hospira is recalling 40,360 vials of Marcaine (bupivacaine hydrochloride) injection because some units contain visible metal particles that discolor 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 FDA classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of metal particulate matter in an injectable drug poses a significant risk of injury.
Plain-English summary
Hospira, Inc. is recalling 40,360 vials of Marcaine (bupivacaine hydrochloride) injection, USP, 0.25%, 30 mL single-dose vials. The affected product is preservative-free, packaged in 10-count vials per carton, and is available by prescription only. The specific lot number is 25-220-DD, with an expiration date of January 2015.
The recall was initiated because units of this lot may contain visible metal particles embedded in the vial and in the solution, which causes the product to be discolored. The product was distributed nationwide.
Healthcare providers and patients should check their inventory for this specific lot number and expiration date. If the product is found, it should be quarantined and not used. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- MARCAINE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- MARCAINE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Affected units
- 40,360
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 25-220-DD
- Exp 1JAN2015
Distribution
Distributed nationwide across the United States.
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Similar recalls
- SevereHospira Recalls Marcaine Injection Vials Due to Visible Metal Particles
FDA (Drugs) · 2014-10-08
- HighHospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter
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