Pfizer’s Hospira Recalls One Lot of Anti-Infective Drug

Hospira, a Pfizer company, is voluntarily recalling one lot of the anti-infective drug, vancomycin hydrochloride (for injection, USP, 750 mg/vial), to the hospital/retailer level due to the presence of particulate matter.

A customer report indicated the presence of particulate matter, confirmed as glass, within a single vial. To date, Hospira said it has not received reports of any adverse events associated with this issue for this lot. The lot was distributed from August 2016 through January 2017 nationwide in the US and Puerto Rico.

In the event the particulate is administered to a patient, it may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

Vancomycin hydrochloride is indicated for treating serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. It is used to treat 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.

Source: FDA

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