Safety Report: All drugs compounded at Edge Pharma - recalled due to lack of sterility assurance, USA

United States

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. The affected lots and expiration dates are included in the link listed below. The names and concentration of the drugs are listed in the link below.

The recall encompasses all compounded sterile and nonsterile drug products, within expiry, that were dispensed from Edge Pharma, LLC. The products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The products can be identified by the label containing the Edge Pharma, LLC name and logo. Edge Pharma, LLC is notifying its customers by email, Media and FDA alerts, and direct outreach.

Consumers and institutions that have Edge Pharma, LLC products should stop using the products immediately and may either return or discard the recalled lots. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Edge Pharma, LLC
Brand name: Edge Pharma, LLC
Product recalled: All drugs compounded at Edge Pharma, LLC
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
FDA Recall date: December 07, 2021

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edge-pharma-llc-issues-voluntary-nationwide-recall-all-drug-products-due-lack-sterility-assurance

Source: FDA