Hospira, a Pfizer company, is recalling one lot of Vancomycin Hydrochloride, an injectable drug used to treat serious or severe infections caused by susceptible strains of methicillin-resistant Staphylococcus due to a confirmed report of particulate matter within a single vial.
If 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. To date, Hospira has not received reports of any adverse events associated with this lot or this issue.
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 as well as 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.
The affected products are packaged in a carton containing 1×100 mL vials. The lot was distributed in the United States from August 2016 through September 2016. Anyone with an existing inventory of this product has been advised to stop use and distribution of the product and to quarantine any inventory immediately.
Any adverse events that may be related to Vancomycin Hydrochloride manufactured by Hospira should file a report with the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.