Hospira, Inc., a provider of injectable drugs and infusion technologies located in Lake Forest, Ill., has issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection due to possible contamination with iron oxide.
The lot was distributed from July 2014 to September 2014. Veterinarians use the drug as a local anesthetic during surgery procedures.
The lot involved in the recall is:
Preservative-Free Bupivacaine HCl Injection
USP: 0.5% (5 mg/mL), 30 mL single-dose
Lot Number: 38-515-DK
Expiration Date: 1FEB2016
According to a press release from the FDA, one confirmed customer complained of visible orange and black particles in one of the single-dose glass teartop vials. The particles were identified as iron oxide.
If injected into a patient the particles may result in local inflammation, low-level allergic or immune response, granuloma formation, or irritation of tissue—particularly in patients that are allergic or sensitive to iron oxide.
To date, Hospira has not received reports of any incidents associated with this recall. The company is currently working with its glass supplier and has initiated an investigation to determine the root cause in order to correct the problem and prevent it from happening again in the future.
Veterinarians with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. Hospira is arranging for impacted products to be returned to Stericycle.
For questions or concerns, contact Hospira Global Complaint Management, Monday through Friday from 8AM to 5PM Central Standard Time, at 1-800-441-4100.