Pharmakon Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to FDA Concern of Lack of Sterility Assurance
Released by David F. McNamar, mcnamarlaw.com; Pharmakon Pharmaceuticals, Inc.
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 email@example.com
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online at www.fda.gov/medwatch/report.htm; or, for regular mail or fax, download form www.fda.gov/MedWatch/getforms.htm or call 800.332.1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 800.FDA.0178.
To see the complete list of products included in this Voluntary Product Recall, see pharmakonmfg.net/pr/
This recall is being conducted with the knowledge of and at the request of the US Food and Drug Administration.
Again, Pharmakon Pharmaceuticals, Inc.’s primary concern is your safety and Pharmakon Pharmaceuticals, Inc. is taking this action out of an abundance of caution.