Injectable Antibiotic Combo Recalled Due to Glass Particles

The administration of a glass particulate may result in local irritation or swelling in response to the foreign material
The administration of a glass particulate may result in local irritation or swelling in response to the foreign material

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. 

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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.