Hospira recalls Vancomycin Hydrochloride after discovery of particulate

The U.S. Food and Drug Administration has announced Hospira, a Pfizer company, has voluntarily recalled one lot of Vancomycin Hydrochloride (VH) at the hospital/retail level in response to the discovery of a particulate matter within a single vial.

VH is intended to treat infections caused by methicillin-resistant staphylococci as well as staphylococcal endocarditis, septicemia, bone infections, lower respiratory tract infections and skin and skin-structure infections. VH also acts as a replacement treatment in penicillin-allergic patients and patients unresponsive to antimicrobials.

While it is unlikely, if the particulate is injected into a patient, it may lead to local swelling, irritation, blockage of blood vessels and a low-level allergic response. Detection is possible by following the procedure on the label and checking the vial for particulate matter and discoloration. Currently, there has not been a report of these effects happening to a patient.

The lot in question was distributed in August and September 2016 in the U.S. Hospira urges any facility with existing VH to stop use, quarantine the product and inform healthcare professionals. Any further distribution should be meet with notifying accounts or locations that have received the product. Hospira will follow with issuing recall letters to direct customers and is in the process of arranging the product to be returned.