Hospira Recalls Bupivacaine Hydrochloride Injection Due to Particulate Matter
Hospira Inc. is recalling 118,100 vials of 0.25% 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 has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Hospira Inc. is recalling 118,100 vials of 0.25% Bupivacaine Hydrochloride Injection, USP, 2.5 mg/mL, 30 mL, Single-dose. The product is identified by NDC 0409-1159-02, Lot # 18-136-DK, and an expiration date of 6/14. The recall was initiated because of the presence of particulate matter, described as visible free floating and partially embedded particles in the glass vials.
The affected product was distributed nationwide. This medication is a human prescription drug intended for epidural, infiltration, intracaudal, and perineural routes of administration. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Healthcare providers and facilities should stop using the affected vials and contact Hospira Inc. for further instructions on returns or replacements. Patients who have received this specific lot of medication should consult their healthcare provider if they experience any adverse effects.
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 118,100
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 # 18-136-DK
- Exp. 6/14
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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