Hospira Issues Recall for Vancomycin Hydrochloride for Injection Due to Potential Contamination
The label contains a clear statement directing physicians to visually inspect the product for particulate matter
Hospira, a Pfizer company, is recalling one lot of Vancomycin Hydrochloride for Injection due to a confirmed customer report of the presence of particulate matter within a single vial.
In the unlikely event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels, and/or low-level allergic response to the particulate. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.
The product is packaged in a carton containing 1x100 mL vial, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017). The affected lot was distributed from August 2016 through September 2016 in the United States.
To date, Hospira has not received reports of any adverse events associated with this issue.
Vancomycin Hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. Vancomycin Hydrochloride is effective in the treatment of staphylococcal endocarditis, septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. It is used in penicillin-allergic patients, and also for patients who cannot receive or who have failed to respond to other antimicrobials, including penicillin or cephalosporin agents, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobials.
Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Inform health care professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail level.
Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States.
Consumers with any additional questions or concerns regarding this recall should contact Stericycle at (888) 570-1678.