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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. Lot AFO l 17001-A, Expiry date Dec 2018 has been found to contain glass particles.
The affected Ampicillin and Sulbactam for Injection lot is packaged in a carton containing 10 vials, NDC: 55150-116-20. The product can be identified as a ‘clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a Royal Blue color polypropylene disc'. AuroMedics shipped the entire lot to wholesalers and/or hospitals nationwide on February 9, 2017.
The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.
BACKGROUND: The product Ampicillin and Sulbactam for Injection is used for treatment of infections due to susceptible strains of designated microorganism in skin and skin structure infections, intraabdominal infections and gynecological infections in adults and for in treatment of skin and skin structure infection in pediatric patient one year and older.
RECOMMENDATION: AuroMedics Pharma LLC is notifying...