Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter
Hospira is recalling Bupivacaine Hydrochloride Injection vials because they contain free-floating and embedded iron oxide particles.
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.
Plain-English summary
Hospira Inc. is recalling 150,950 vials of Bupivacaine Hydrochloride Injection, USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials. The recall is due to the presence of particulate matter, specifically free-floating and embedded iron oxide particles.
The affected product is identified by Lot # 38-515-DK and has an expiration date of February 1, 2016. The product is distributed nationwide in the U.S., including Guam. It is a prescription-only medication used for epidural, infiltration, intracaudal, and perineural routes.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or returns.
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Affected units
- 150,950
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 #: 38-515-DK
- Expiry: 1 FEB 2016.
Distribution
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