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 FDA’s 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.
Pharmakon Pharmaceuticals, Inc. is notifying its customers that received sterile compounded products via email and is arranging for return of all recalled products.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online
- Regular Mail or Fax: download the form 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
This recall is being conducted with the knowledge of and at the request of the FDA.
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