The Food and Drug Administration (FDA) on January 4 announced the recall by AuroMedics Pharma LLC (Windsor, New Jersey) of one lot of Ampicillin and Sulbactam for Injection USP 1.5 g in a single-dose vial.
The recall was issued because the lot (Lot AFOI 17001-A, Expiry date December 2018) was found to contain glass particles.
The affected lot is packaged in a carton containing 10 vials, NDC: 55150-116-20. AuroMedics shipped the entire lot to wholesalers and hospitals nationwide on February 9, 2017.
To date, AuroMedics has not received any reports of adverse events or identifiable safety concerns attributed to the product.
Posted 01/04/2018] AUDIENCE: Pharmacy, Risk Manager ISSUE: AuroMedics Pharma is voluntarily recalling one lot of Ampicillin and Sulbactam for Injection USP, 1.5 g in a Single-Dose vial (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt), to the hospital level.