Recall Issued for Sterile Compounded Products
Pharmakon Pharmaceuticals Inc voluntarily recalls sterile compounded products due to sterility and quality concerns.
Pharmakon Pharmaceuticals Inc is voluntarily recalling all lots of its sterile compounded products due to sterility and quality concerns.
The FDA warned that the use of contaminated products could potentially cause life-threatening infections or death in patients.
To date, Pharmakon Pharmaceuticals has not received word of any adverse effects related to these projects.
“Pharmakon Pharmaceuticals Inc’s primary concern is your safety, and Pharmakon Pharmaceuticals Inc is taking this action out of an abundance of caution,” an FDA press release stated.
The products are used for a variety of indications and come in bags, syringes, and cad cassettes.
All of the products would also have the Pharmakon Pharmaceuticals label and address on them. The products were distributed to hospitals between March 4, 2016, and April 15, 2016.
Hospitals that may have received Pharmakon Pharmaceuticals compounded products during these dates are advised to discontinue use. Additionally, facilities should quarantine all unused products. Medical professionals can contact Pharmakon Pharmaceuticals via phone 888-660-6715 x251 to arrange a return of unused products.
Adverse reactions stemming from the contaminated pharmaceutical products can be reported to the FDA’s MedWatch Adverse Event Reporting program online or via mail or fax.