Hospira is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, 750mg/vial. The recall is due to a confirmed customer report of glass within a single vial.
The product has Lot #632153A and the NDC of the recalled lot is 0409-6531-02. The lot was distributed in the U.S. and Puerto Rico between August 2016 and January 2017; the Expiry Date is ’01 MAR 2018′.
Hospira has, to date, not received reports of any adverse events associated with the recalled lot. Administration of an injectable product containing a particulate may result in phlebitis, end-organ granuloma or micro-embolic effects.
Vancomycin HCl is indicated for the treatment of serious or severe infections due to susceptible methicillin-resistant (beta-lactam-resistant) staphylococci in penicillin-allergic patients; patients who cannot receive or have failed to respond to other drugs, including penicillins and cephalosporins; and for infections due to vancomycin-susceptible organisms resistant to other antimicrobials; staphylococcal endocarditis, including septicemia, and infections of the lower respiratory tract, bone, and skin and skin structure; streptococcal endocarditis due to S. viridans or S. bovis as monotherapy or in combination with an aminoglycoside; enterococcal endocarditis due to E. faecalis in combination with an aminoglycoside; diphtheroid endocarditis; and early-onset prosthetic valve endocarditis due to S. epidermidis or diphtheroids in combination with rifampin, or an aminoglycoside, or both.
Adverse events related to this product recall should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
For more information visit FDA.gov.