The FDA expressed doubts over the safety of the manufacturer's products
Pharmakon Pharmaceuticals has announced that is voluntarily recalling all lots of aseptically compounded sterile products. The move from the drug manufacturer comes after the Food and Drug Administration (FDA) expressed concern over a lack of sterility assurance and other quality issues.
The compounded sterile products have a variety of uses and may be packaged in bags, syringes, or cad cassettes. All recalled products have a label that includes the Pharmakon name, address, and expiration date.
The affected products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016.
The use of a product with questionable sterility may result in serious and potentially life-threatening infections or death.
To date, the company has not received any reports of adverse effects or injuries.
Pharmakon is notifying its customers via email and is arranging for return of all recalled products.
Hospitals in possession of the products should discontinue use, quarantine any remaining product, and contact the manufacturer at (888) 660-6715 extension 251.
Customers with questions about this recall can contact Pharmakon by phone at (888) 660-6715 or by email at email@example.com.