Injectable Antibiotic Drug Recalled
Vancomycin Hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci.
Hospira announced a voluntary recall of Vancomycin HCl for Injection, USP, after a confirmed customer report of particulate matter discovered in a single vial.
The affected product has NDC #0409-6510-01, Lot # 591053A and an expiration date of November 1, 2017. The product was supplied in a carton containing 1x100mL vial and was distributed from August 2016 through September 2016. If the particulate is administered to a patient, he or she may experience local swelling, irritation of blood vessel or tissue, blockage of blood vessels, and/or low-level allergic response to the particulate.
Vancomycin HCl is an antibiotic indicated to treat serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. Vancomycin HCl effectively treats staphylococcal endocarditis, septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. It is a treatment option for patients with a penicillin allergy or for those who cannot receive or who have failed to respond to other antimicrobials (penicillin or cephalosporin drugs), and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobials.
The manufacturer has not received reports of any adverse events associated with this issue for this lot. Anyone with an existing inventory of the recalled lot should discontinue use and quarantine the product immediately. Hospira will be contacting its direct customers and is arranging for returns of affected products.
For more information call (800) 615-0187 or visit Hospira.com.
Hospira issues a voluntary nationwide recall for one lot of Vancomycin Hydrochloride for Injection, USP due to the presence of particulate matter within a single vial [news release]. Silver Spring, MD: US Food and Drug Administration; January 24, 2017.