AuroMedics Pharma Recalls Ampicillin and Sulbactam for Injection

January 4, 2018

The company is voluntarily recalling product because of glass particles found in vials.

On Jan. 3, 2018, AuroMedics Pharma LLC announced it was voluntarily recalling lot AFO l 17001-A of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level.  The product is being recalled after glass particulates were found in vials.

According to the company, if glass is present in the intravenous drug and is administered, reactions from local irritation and swelling to more serious conditions such as blockage and clotting in blood vessels may occur. No adverse events have been reported as of January 3.

The affected lot has an expiration date of December 2018 and is packaged in a carton containing 10 vials, NDC: 55150-116-20. The lot was shipped to wholesalers and/or hospitals nationwide on Feb. 9, 2017.

Ampicillin and Sulbactam for Injection is used to treat infections “due to susceptible strains of designated microorganism in skin and skin structure infections, intra­abdominal infections, and gynecological infections in adults and for treatment of skin and skin structure infection in pediatric patient one year and older,” according to a press release.

Source: FDA