AUDIENCE: Pharmacy, Anesthesiology, Veterinary
ISSUE: Hospira issued 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.
BACKGROUND: The lot was distributed from July 2014 to September 2014. Hospira is currently working with its glass supplier and has initiated an investigation to determine the root cause and corrective and preventive actions.
RECOMMENDATION: 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). Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-866-918-8770 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[04/23/2015 - Press Release - Hospira]