Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter
Hospira Inc. is recalling 115,500 vials of Bupivacaine Hydrochloride injection due to a confirmed report of visible particulate matter embedded in the glass vials.
What this means for you
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 involves a risk-of-harm product (injectable medication with particulate matter) where injury has not yet been reported, aligning with the High severity criteria.
Plain-English summary
Hospira Inc. is recalling 115,500 vials of Bupivacaine Hydrochloride Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial. The product is identified by Lot 25-097-DK with an expiration date of 01/01/2015 and NDC 0409-1162-02. The recall was initiated following a confirmed customer report of visible particulate matter embedded in the glass vial.
The affected product was distributed nationwide. Bupivacaine Hydrochloride is a prescription-only medication used for epidural, infiltration, intracaudal, and perineural routes. The presence of particulate matter in an injectable medication poses a potential safety risk to patients.
Healthcare providers and facilities that have received this product should stop using it immediately and contact Hospira Inc. for further instructions. Patients who have received this specific lot should consult their healthcare provider if they have any concerns or experience adverse effects.
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 115,500
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 25-097-DK
- Exp 01/01/2015
Distribution
Distributed nationwide across the United States.
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