The United States: Auromedics Pharma LLC issues voluntary nationwide recall of product: Piperacillin and Tazobactam for injection, USP 3.375 g (English Only)
 
The US Food and Drug Administration (FDA) announces that 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. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial. 

The affected Piperacillin and Tazobactam for Injection lots being recalled are PP0317061-A, Exp. Aug 2019, and PP0317049-A, Exp. Aug 2019. The product is packaged in a carton containing 10 single-dose vials. 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 lots to wholesalers and/or hospitals nationwide 6 Dec 2017 through 25 Apr 2018. 

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 LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots. 

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm606789.htm 

In Hong Kong, the above product is not a registered pharmaceutical product. 

Ends/Tuesday, May 8, 2018 
Issued at HKT 16:00 

  轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/