AuroMedics Pharma LLC is recalling one lot of an injectable antibiotic because glass particles were found floating in a single-dose vial. If glass is present in an intravenous drug and the drug is administered, it may cause local irritation or swelling. More serious complications that can occur include blockage and clotting in the blood vessels, which may be deadly. To date, AuroMedics Pharma has not received any reports of adverse effects related to this recall.
The recall affects lot AFO l 17001-A, with the expiration date “Dec 2018” 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.
Ampicillin and Sulbactam injection is used to treat infections due to susceptible strains of designated microorganisms in the 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 of age and older.
The affected product is package in a carton containing 10 vials with the 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. The lot was shipped to wholesalers and/or hospitals nationwide on Feb. 9, 2017.
AuroMedics is notifying its distributors and customers and arranging for return and replacement of the recalled products. Any adverse events related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice