A confirmed customer report of the presence of particulate matter within a single vial prompted Hospira to recall the injectable antibiotic, FDA officials announced.
Hospira is voluntarily issuing a nationwide recall of 1 lot of vancomycin hydrochloride for injection, USP (NDC: 0409-6510-01, Lot 591053A). A confirmed customer report of the presence of particulate matter within a single vial prompted Hospira to recall the injectable antibiotic, FDA officials announced.
If a patient receives an injection containing the particulate, it may cause local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response. Vancomycin HCl is used to treat serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. Patients who have a penicillin allergy or do not respond to other antimicrobials are also treated with the antibiotic.
Vancomycin HCl was distributed between August 2016 and September 2016 in the United States in a carton containing 1x100 mL vial. Health care providers are encouraged to report any adverse reactions or quality problems associated with the use of this product to FDA’s MedWatch Adverse Event Reporting program. Hospira has not yet received reports of adverse events associated with the particulate.
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]. FDA’s website. http://www.fda.gov/Safety/Recalls/ucm538214.htm. Accessed Jan. 25, 2017.