AuroMedics Pharma is recalling two lots of the injectable antibiotics piperacillin and tazobactam after discovering that some vials contain particulate matter visible only after reconstitution. The particulate was confirmed to be glass within the vial.
If the glass particulate is administered to a patient, it could cause local irritation or swelling. More serious potential complications include blockage and clotting in blood vessels, which may be life-threatening. To date, AuroMedics Pharma has not received any reports of adverse events related to this recall.
Piperacillin and tazobactam injections are used to treat 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.
AuroMedics Pharma is notifying its distributors and customers of this recall and arranging for return or replacement of all recalled products. Anyone who has possession of affected products should immediately stop using them and return them to the place of purchase, and contact their doctor, if appropriate.
Any adverse events related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice