Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter
Hospira Inc. is recalling 75,000 vials of Bupivacaine Hydrochloride 0.5% due to a confirmed report of a brown, rust-colored particle embedded in the glass vial.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter in an injectable drug, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Hospira Inc. is recalling 75,000 vials of Bupivacaine Hydrochloride Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free. The affected product is identified by Lot 37-268-DK with an expiration date of January 2016. The product is distributed nationwide and is indicated for nerve block, caudal, and epidural anesthesia, but not for spinal anesthesia.
The recall was initiated following a confirmed customer complaint reporting the presence of a brown, rust-colored particle embedded at the bottom of the glass vial. This particulate matter presents a potential safety risk for patients receiving the medication.
Healthcare providers and patients should stop using the affected vials immediately. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recall description, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 75,000
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 37-268-DK
- Exp: 1JAN2016
Distribution
Distributed nationwide across the United States.
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