Hospira Recalls Marcaine Injection Vials Due to Visible Metal Particles
Hospira is recalling 85,680 vials of Marcaine (bupivacaine HCl) injection because a customer complaint confirmed the presence of visible metal particles and discolored solution.
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 indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
Hospira Inc. is recalling 85,680 vials of Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial. The recall is limited to Lot # 34-440-DD, which has an expiration date of 10/15. The product is distributed nationwide.
The recall was initiated following a confirmed customer complaint regarding the presence of particulate matter. The complaint described a discolored solution with visible metal particles embedded in the glass vial and visible in the solution. The FDA has classified this recall as Class I.
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 recalled lot, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- MARCAINE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- MARCAINE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 85,680
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 #: 34-440-DD
- Exp 10/15
Distribution
Distributed nationwide across the United States.
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Similar recalls
- SevereHospira Recalls Marcaine Injection Vials Due to Visible Metal Particles
FDA (Drugs) · 2014-10-08
- SevereHospira Recalls Marcaine Injection Vials Due to Metal Particulate Matter
FDA (Drugs) · 2014-03-26
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- SevereHospira Recalls Marcaine Injection Due to Sterility and Potency Issues
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