AuroMedics Pharma is voluntarily recalling Ampicillin and Sulbactam for injection and Piperacillin and Tazobactam for injection.
Ampicillin and Sulbactam for Injection
AuroMedics Pharma announced a recall of two lots of Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose vials, to the hospital/user level. The recall has been 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.
In the event the 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. Patients with vascular disease may be at particular risk of embolic events which could cause permanent impairment or damage to a body structure or function. The risk is reduced by the possibility of detection.
To date, AuroMedics Pharma has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots.
Background
Ampicillin and Sulbactam for Injection is an intravenously or intramuscularly administered antibiotic used for the treatment of infections due to susceptible strains in adults and pediatric patients one year and older. It is packaged in a carton containing 10 vials, NDC 55150-117-20. The affected Ampicillin and Sulbactam for Injection lots being recalled are AS0317041-A, Exp. Aug 2019, and AS0317035-A, Exp. Aug 2019.
Piperacillin and Tazobactam for Injection
The recall is for two lots of Piperacillin and Tazobactam for Injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level.
The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial. 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 has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots.
Background
Piperacillin and Tazobactam for Injection is used for treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in intra-abdominal, skin and skin structure and female pelvic infections as well as community acquired and nosocomial pneumonia.
It is packaged in a carton containing 10 single-dose vials, NDC: 55150-120-30. The affected Piperacillin and Tazobactam for Injection lots being recalled are PP0317061-A, Exp. Aug 2019, and PP0317049-A, Exp. Aug 2019.
(Source: The U.S. Food & Drug Administration)
