AuroMedics Pharma LLC 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.
One vial from lot #PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot #PP0317059-A was found to contain silicone material. This problem was discovered as a result of two product complaints in which the contents of one vial from batch PP0317012-A was found to contain a glass particle and the contents of one vial from batch PP0317059A was found to contain a silicone particle.
Risk Statement: The administration of glass or silicone particulates 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 consumed from these lots.
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 PP0317059-A; Exp. February 2019: PP0317012-A, Exp. August 2019.
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 PP0317012-A to wholesalers and/or hospitals nationwide June 30, 2017. Lot PP0317059-A was shipped 27 November 2017 through 29 January 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 lots which are being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate.
(Source: The U.S. Food and Drug Administration)
