AuroMedics Pharma Issues Recall Due to Glass Particulates in Vials

The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.
May 16, 2018
By BioPharm International Editors

On May 14, 2018, AuroMedics Pharma LLC announced it is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g in a single-dose vial, to the hospital level. The recall comes after glass particulates were found within a vial.

The affected product is packaged in a carton containing 10 single-dose vials, NDC:  55150-120-30, PP0317061-A, expiration August 2019, and PP0317049-A, expiration August 2019. The lots were shipped to wholesalers and/or hospitals nationwide Dec. 6, 2017 through Apr. 25, 2018.

According to the company, 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. Use of product containing glass particulates could result in local irritation or swelling. Blockage and clotting of blood vessels may also occur.

No adverse events connected to the product have been reported as of May 14, 2018. Adverse events may be reported to FDA via the agency’s MedWatch program.

Source: FDA

 

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