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Piperacillin And Tazobactam For Injection, Usp 3.375g Vials By Auromedics Pharma: Recall- Vails Contain Particular Matter

The National Agency for Food and Drug Administrative Control (NAFDAC) has been informed by the US FDA that Auromedics Pharma is voluntarily recalling two lots of piperacillin and Tanzobactam sodium equivalent to 0.375g of Tanzobactam USP.

The products have been found to contain particulate matter confirmed to be glass within the vial. The particulate matter is visible only after reconstitution.

The administration of a glass particulate in an intravenous drug may result in local irritation or swelling in response to the foreign material. More serious potential outcome would include blockage and clotting in blood vessels which may be life threating.

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 nosocominal pneumonia.

Affected Product Details

Piperacillin and Tanzobactam for injection is packaged in a carton containing 10 single – dose vails, NDC: 55150-120-30. The affected lots being recalled areas follows

Product Lot Number Expiration Date
Piperacillin and

Tanzobactam for

Injection.

PP0317061-A

And

PP0317049-A

Aug. 2019

 

Aug. 2019

 

Healthcare Provider Action

Auromedics pharma is notifying its distributors and customers by recall latter and is arranging for return/replacements of all recalled products

All healthcare providers in possession of the affected lots of the product should immediately stop using them and submit any quantity in their possession to the nearest NAFDAC office.

Distributors/Retailers that have the affected product should immediately stop their sale and contact their suppliers

Adverse events following the use of this product should be reported to NAFDAC via PRASCOR(20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng.

NAFDAC…………..Safeguarding the Health of the Nation!!!

Signed: Management