Pharmakon Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to FDA Concern of Lack of Sterility Assurance

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

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: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Voluntary Product Recall List: https://pharmakonmfg.net/pr/

This recall is being conducted with the knowledge of and at the request of the U.S. 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. Thank you for your support.

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