Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance

If your email program has trouble displaying this email, view as a webpage. Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance FOR IMMEDIATE RELEASE – December 4, 2021 – Colchester, VT, Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC to the consumer level. All products are being recalled due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products. Risk Statement: 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. To date, Edge Pharma, LLC has not received and is not aware of any adverse events related to this recall. The products are used for a variety of indications and are packaged in Containers, IV bags, Syringes, Drop containers, Vials, Bottles, and Jars.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to edwardlorilla1986.paxforex@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA