Edge Pharma, LLC voluntarily recalled all lots of all drug products compounded and distributed at its Colchester, Vermont facility.
All products are being taken off the market because of process issues that could affect the sterility of the medications and could also impact the safety and quality of its non-sterile products.
The company, however, didn’t specify what the process issues were.
How can this affect consumers?
Using a drug that’s supposed to be sterile but actually isn’t can result in site-specific infections as well as serious systemic infections that can potentially be life-threatening, Edge Pharma said.
The company has recalled a wide array of products that are used for different indications and are packaged in:
- Containers
- IV Bags
- Drop Containers
- Syringes
- Bottles
- Jars
- Vials
The drug pullout also affected products such as:
- Lidocaine
- Mitomycin
- Vancomycin
- Dexamethasone
Overall, the recall by Edge Pharma covered more than 60 lots of company-made drugs. The products can be identified through their label that contains the Edge Pharma, LLC name and logo. The affected lots and expiration dates are included in this link.
What You Can Do
The drug products covered in the recall were distributed nationwide and directly to consumers and/or medical facilities.
According to the recall notice, Edge Pharma is now in the process of notifying customers about the recall through email, Media and FDA Alerts, and direct outreach. It is also advised that consumers and institutions that are in possession of the affected products to stop using the medications immediately.
They have the option to return or discard the impacted lots. As of Dec. 7, Edge Pharma, LLC said it hasn’t received any reports of adverse events related to the recall.
Any adverse reactions or problems experienced with the affected products should be reported to the FDA’s MedWatch Adverse Event Reporting program by completing the report online.
