All Lots of All Drugs Compounded by Edge Pharma Recalled

SIS Patient Safety Alert 12/08/2021: All Lots of All Drugs Compounded by Edge Pharma Recalled

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither SIS nor the FDA endorse either the product or the company.

ISSUE: Edge Pharma is recalling all lots of all drugs compounded at Edge Pharma, 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, has not received and is not aware of any adverse events related to this recall. Click here for more information.

BACKGROUND: The products being recalled are used for a variety of indications and are packaged in Containers, IV bags, Syringes, Drop containers, Vials, Bottles, and Jars.

RECOMMENDATIONS:

• Consumers and institutions that have Edge Pharma 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. 

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Adverse Event Reporting Program:

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178
  

Help sustain this vital dissemination of patient safety information with your donations. The Spine Intervention Society (SIS) is a tax exempt organization under US section 501(c)(3) of the Internal Revenue Code. As such, contributions are deductible to the extent allowed by law.