Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter
Hospira Inc. is recalling 143,250 vials of Bupivacaine Hydrochloride Injection due to a confirmed report of particulate matter in a single vial.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical).
Plain-English summary
Hospira Inc., a Pfizer company, is recalling 143,250 vials of Bupivacaine Hydrochloride Injection, USP (2.5 mg/mL) 0.25%. The affected product is packaged in 30 mL single-dose preservative-free vials and is identified by Lot # 59064DK with an expiration date of 11/17. The product was distributed nationwide.
The recall was initiated following a confirmed customer report regarding the presence of particulate matter within a single vial. Bupivacaine Hydrochloride is a prescription-only medication used for epidural, infiltration, intracaudal, and perineural routes.
Healthcare providers and patients should discontinue use of the affected lot and contact Hospira for further instructions. This recall is classified as Class I by the FDA.
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc., A Pfizer Company
- Category
- Drug — Injection
- Hazard
- Affected units
- 143,250
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 # 59064DK
- Exp. 11/17
Distribution
Distributed nationwide across the United States.
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