Downing Labs Recalls All Sterile Compounded Products Due to Lack of Sterility Assurance

Downing Labs is voluntarily recalling all lots of sterile products compounded and packaged by Downing Labs and that remain within expiry due to concerns over sterility assurance. The products were distributed nationwide and in the UK to patients and providers between April 20, 2015 and September 15, 2015. The recall does not pertain to any non-sterile compounded medications prepared by Downing Labs.

If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. There have been no consumer complaints or reports of any issues with the recalled products to date. Downing Labs takes this measure voluntarily and solely out of an abundance of caution because Downing Labs takes the utmost care to ensure patient safety. Thus, Downing Labs is asking all patients and providers that received sterile compounded products from Downing Labs between April 20, 2015 and September 15, 2015 that remain within expiry to take the following actions:

1. Discontinue use of the products;
2. Set aside any unused product until further instructions are received on how to return the product; and

Contact Downing Labs at 800-914-7435 from the hours of 8:30AM-5:00PM central time Monday-Friday, or e-mail at [email protected] to discuss the return of any unused sterile compounded products.