Hospira Inc., a Pfizer company, is recalling one lot Vancomycin Hydrochloride for injection after glass particles were seen floating in a single vial of the staph infection treatment. In the event the glass particulate is administered to a patient, it may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma. To date, Hospira has received no reports of adverse events related to this issue.
Vancomycin Hydrochloride is used to treat serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. It is effective in treating staphylococcal endocarditis, septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections.
It is also used in penicillin-allergic patients, and for patients who cannot receive or who have failed to response to other antimicrobials, including penicillin or cephalosporin agents, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobials.
The recall involves Vancomycin Hydrochloride USP, 750 mg/vial NDC: 0409-6531-02, Lot 632153A, Expiry Date 01 MAR 2018, is packaged in a carton containing 10 units. The lot was distributed from August 2016 through January 2017 nationwide in the United States and Puerto Rico. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Hospira will be notifying its customers about the recall. Any adverse events related to use of this product should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice