AuroMedics recalls antibiotics due to ‘particulate matter’ in product
The recall pertains to two lots of Ampicillin and Sulbactam for Injection USP, 3 grams/Single-Dose vial, to the hospital/user level.
According to the announcement from the US Food and Drug Administration (FDA), the recall was initiated due to “customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients.”
Per the announcement’s risk statement if a particulate is administered to the patient, it may result in “local site reaction, phlebitis, pulmonary granuloma, occlusion of blood vessels, thromboembolic events and systemic immune response.”
The company has not has not received adverse event reports and is arranging for the return and replacement of the recalled product.
The affected Ampicillin and Sulbactam for Injection lots being recalled are AS0317041-A, Exp. Aug 2019, and AS0317035-A, Exp. Aug 2019.
