Compounder Recalls All Products

Edge Pharma is voluntarily recalling all lots within expiry of all drugs it compounded and dispensed because of a lack of sterility assurance. The recall includes products intended to be sterile as well as nonsterile products, which the company said may have safety and quality problems stemming from process issues. The products cover a variety of indications and are packaged in containers, IV bags, syringes, drop containers, vials, bottles, and jars.

“Administration of a drug product intended to be sterile, that is not sterile, could result in site-specific infections as well as serious systemic infections which may be life-threatening,” the company stated in a December 4, 2021, announcement. “To date, Edge Pharma, LLC, has not received and is not aware of any adverse events related to this recall.”

Products affected by the recall were distributed throughout the United States to medical facilities as well as directly to customers. Labels on the products include the Edge Pharma name and logo.

The firm released a 9-page document listing more than 50 products included in the recall, as well as their specific lot numbers, expiry dates, and dates of distribution.