Drug Safety Alerts

Ampicillin and Sulbactam for Injection Class I Recall

2/14/18

On February 14, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of ampicillin and sulbactam for injection 1.5 g vials (NDC # 55150-0116-20).This recall was issued because the product has been found to contain glass particles. 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. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product.

This recall affects lot # AF0117001-A exp. 12/31/18. No other lots are affected by this recall.

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, intra- abdominal infections and gynecological infections in adults and for in treatment of skin and skin structure infection in pediatric patient one year and older. The affected Ampicillin and Sulbactam for Injection lot being recalled is AF0117001-A, EXP. December 2018. It 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.

This recall was originally issued to the hospital/retail-level on January 3, 2018. The FDA classified this as a Class I on February 14, 2018.

AuroMedics Pharma LLC is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. Consumers/distributors/retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate.

Consumers with questions regarding this recall can contact AuroMedics Customer Service Monday through Friday from 9:00AM to 5:00PM EST at 1-888-238-7880 Option 1. If you need assistance in returning your product or have questions about the recall process, contact Inmar at 1-800-967-5952, Monday through Friday from 8:30 AM to 5:00 PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact AuroMedics Customer Service at 1-888-238-7880, Monday through Friday, 9:00 am to 5:00 pm (ET) and select option 1.You may also call the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.accessdata.fda.gov.