News & Press: Patient Safety

Hospira Issues A Voluntary Nationwide Recall Of One Lot Of Bupivacaine HCl Injection Due To Potentia

Friday, April 24, 2015  
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Hospira, Inc. has announced today it is issuing a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as iron oxide. This recall is being carried out to the user level (both human and veterinary).

Risk factors associated with particulate include the potential for particulate to be injected and/or therapy may be delayed. If smaller pieces of the particulate break off and become free floating within the solution, it may be injected into the patient. Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue, in particular in patients allergic or sensitive to iron oxide. In addition, therapy may be delayed if observation of particulate is not made until the point of care. This delay is likely to be of negligible clinical significance provided remediation is readily available.

The lot was distributed from July 2014 to September 2014. Hospira has not received reports of any adverse events associated with this issue for this lot to date. Hospira is currently working with their glass supplier and has initiated an investigation to determine the root cause and corrective and preventive actions.

Anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the user level (both human and veterinary).

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program:

  • Complete and submit the report online at; or download and complete the form, then submit it via fax at 1-800-FDA-0178.
  • Read the FDA News Release, including a link to the press release, HERE.

    Source: U.S. Food and Drug Administration (FDA) (Accessed: 04/24/2015)

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