The Recall Desk
SevereFDA (Drugs)·D-0002-2015·Announced 2014-10-08

Hospira Recalls Marcaine Injection Vials Due to Visible Metal Particles

Hospira is recalling 40,730 vials of Marcaine (bupivacaine hydrochloride) injection because of a confirmed complaint of visible metal particles in the solution.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.

Plain-English summary

Hospira Inc. is recalling 40,730 vials of Marcaine (bupivacaine hydrochloride) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial. The affected product is identified by Lot # 33-545-DD and has an expiration date of 09/15. The product was distributed nationwide.

The recall was initiated due to 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.

Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or a replacement.

The recalled product

Product
MARCAINE (BUPIVACAINE HYDROCHLORIDE)
Brand
MARCAINE
Manufacturer
Hospira Inc.
Category
Drug — Injectable Anesthetic
Hazard
Affected units
40,730

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 # 33-545-DD
  • Exp. 09/15

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · MARCAINE

Same manufacturer · Hospira Inc.

See all →

Same hazard · particulate matter

See all →