Hospira Recalls One Lot of Injectable Vancomycin Hydrochloride

August 31, 2017

Hospira, a Pfizer company, is voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial because of glass within a single vial.

On Aug. 30, 2017, Hospira, a Pfizer company, announced it was voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was because of a confirmed customer report for the presence of glass within a single vial. The lot was distributed nationwide in the United States and Puerto Rico from August 2016 through January 2017.

Vancomycin hydrochloride is indicated for treating serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. The drug is effective in treating staphylococcal endocarditis, septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. It may also be used by patients allergic to penicillin, or who have not responded to other antimicrobials.

Possible adverse events associated with use of the contaminated vial include phlebitis, end-organ granuloma or micro-embolic effects, and gastrointestinal trauma. These events can be prevented by checking the vial for particulate matter and discoloration before administration.

The company has initiated an investigation to determine the root cause and corrective and preventive actions. To date, no adverse events associated with this issue for this lot have been reported to the company.

Source: FDA