FDA MedWatch - All Drug Products by Edge Pharma:

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TOPIC: All Drug Products by Edge Pharma: Recall - Due to Lack of Sterility Assurance

AUDIENCE:  Patient, Health Professional, Risk Manager, Pharmacy

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.

For more information about this recall, click on the red button "Read Recall" below.

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 Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.