Hospira Recalls Bupivacaine Hydrochloride Injection Due to Particulate Matter
Hospira Inc. is recalling 119,600 vials of Bupivacaine Hydrochloride Injection due to the presence of visible particulate matter.
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 FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Hospira Inc. is recalling 119,600 vials of 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose. The product is identified by NDC 0409-1165-02, Lot # 23-338-DK, and an expiration date of 11/14. The recall was initiated because of the presence of visible free-floating and partially embedded particulate matter in the glass vials.
The affected product was distributed nationwide. Bupivacaine Hydrochloride is a prescription drug used for epidural, infiltration, intracaudal, and perineural routes. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or to arrange for a return or replacement. Consumers should verify the lot number and expiration date on their medication to determine if it is affected by this recall.
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 119,600
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 # 23-338-DK
- Exp. 11/14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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