AuroMedics Pharma announced a voluntary recall of 1 lot of Ampicillin and Sulbactam for Injection 1.5g single-dose vials after the detection of glass particles.
Ampicillin and Sulbactam for Injection is a combination antibiotic indicated to treat susceptible skin and skin structure infections, intraabdominal infections, and gynecological infections in adults and for the treatment of skin and skin structure infections in pediatric patients 1 year and older. It combines ampicillin, a broad-spectrum penicillin, and sulbactam, a beta-lacatamase inhibitor.
The affected product has Lot # AFO | 17001-A, NDC 55150-116-20, and an expiration date of Dec 2018. It is supplied as a carton containing 10 vials and was shipped to wholesalers and/or hospitals on February 9, 2017.
Administration of a glass particulate from an intravenous (IV) drug may cause local irritation or swelling in response to the foreign object. Blockage and clotting in blood vessels may result as a more serious and life-threatening outcome.
The Company is alerting its distributors and customers via recall letters and is arranging for return or replacement of all affected products.
For more information call (888) 238-7880 or visit FDA.gov.