Pharmakon Pharmaceuticals, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by Pharmakon Pharmaceuticals, Inc. that remain within expiry due to the Food and Drug Administration’s (FDA) concern over a lack of sterility assurance and other quality issues. Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death. To date, Pharmakon Pharmaceuticals, Inc. has not received any reports of adverse effects or injuries.
These compounded sterile products are used for a variety of indications and are packaged in bags, syringes and cad cassettes. All recalled products have a label that includes the Pharmakon Pharmaceuticals, Inc. name, address and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016.
As Pharmakon Pharmaceuticals, Inc. takes the utmost care to ensure patient safety and out of an abundance of caution, then, Pharmakon Pharmaceuticals, Inc. is notifying its customers that received sterile compounded products via email and is arranging for return of all recalled products. All hospitals that received sterile compounded products from Pharmakon Pharmaceuticals, Inc. between March 4, 2016 and April 15, 2106 and that remain within expiry, to take the following actions:
- Discontinue use of the products
- Quarantine any unused product
- Contact Pharmakon Pharmaceuticals, Inc. at 888-660-6715 x251 from the hours of 8:30am 5:00pm Eastern Standard Time Monday-Friday to discuss the return of any unused sterile compounded products
Customers with questions can contact Pharmakon Pharmaceuticals, Inc. by phone 888-660-6715 Monday-Friday, 8:00am to 5:00pm Eastern Standard Time, or email at contactmfg@pharmakonrx.net
quoted from http://www.fda.gov/Safety/Recalls/ucm496838.htm
No comments:
Post a Comment