All Drug Products by Edge Pharma: Recall

December 10, 2021
All Drug Products by Edge Pharma: Recall – Due to Lack of Sterility Assurance

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 concentrations of the drugs are listed in the table following this release.

LINK TO LOT NUMBERS, DISTRIBUTION DATES &