Hospira Recalls Bupivacaine Hydrochloride Vials Due to Sterility Concerns
Hospira Inc. is recalling 65,109 vials of Bupivacaine Hydrochloride with Epinephrine due to a potential breach in the aseptic process caused by equipment failure.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a drug with a potential sterility breach (risk of serious infection) falls under the 'Severe' category, as it represents a significant risk of harm even without reported hospitalizations.
Plain-English summary
Hospira Inc. is recalling 65,109 vials of Bupivacaine Hydrochloride 0.5% and Epinephrine 1:200,000 Injection, 50 mL, Multiple-dose Fliptop Vial. The affected product is identified by NDC #0409-9046-01 and includes Lot #32-484-EV and Lot #32-485-EV, both with an expiration date of 2/2015.
The recall was initiated because an equipment failure led to a potential breach in the aseptic process, resulting in a lack of assurance of sterility. The product was distributed nationwide in the United States.
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 of the product.
The recalled product
- Product
- BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 65,109
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 #32-484-EV
- 32-485-EV Exp: 2/2015.
Distribution
Distributed nationwide across the United States.
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