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
