Audience

Risk manager, infectious disease, pharmacy, nursing

Issue

AuroMedics Pharma is voluntarily recalling 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.

Recommendation

AuroMedics Pharma 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 lots that are 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 on weekdays from 9:00 a.m. to 5:00 p.m. EST at 888-238-7880 Option 1. If you need assistance in returning your product or have questions about the recall process, contact Inmar at 800-967-5952 on weekdays 8:30 a.m. to 5:00 p.m. EST.

Consumers should contact their physician or health-care provider if they have experienced any problems that may be related to taking or using this drug product.