Medication Monitor

Generic Name (Trade Name—Company)
October 23, 2015

Multiple generic names

(No trade names—Downing Labs)
All lots of sterile compounded products recalled because of lack of sterility assurance

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

If there is a contamination in products intended to be sterile, patients are at risk of serious, possibly life-threatening infections. There have been no consumer complaints or reports of any issues with the recalled products to date.

Patients and providers who received the products should discontinue use of the products, set aside any unused products until further instructions are received on how to return them, and contact Downing Labs at 800-914-7435 between 8:30 a.m. and 5:00 p.m. central time Monday through Friday or via e-mail at

Patients should contact their physician or health care provider if they have experienced any problems that may be related to using this drug product. Providers who have dispensed any sterile product distributed by Downing Labs to a patient(s) for use outside of the provider's office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall.