Compounding Pharmacy Issues Recall

September 24, 2015
BioPharm International Editors

US Compounding, Inc. issues voluntary recall of all sterile products.

 

FDA announced on Sept. 21, 2015 that US Compounding has voluntarily recalled all lots of sterile products compounded and packaged by the company; non-sterile compounded products are not being recalled. The recall is in response to FDA’s concern regarding a lack of sterility assurance. The affected lots were distributed nationwide between March 14, 2015 and Sept. 9, 2015.

US Compounding states, in a press release, that “If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk. As USC takes the utmost care to ensure patient safety and out of an abundance of caution, then, USC is asking all patients and providers that received sterile compounded products from USC between March 14, 2015 and September 9, 2015, and that remain within expiry, to take the following actions: discontinue use of the products; quarantine any unused product until further instructions are received on how to return the product; and contact USC at 800.718.3588 x254 or 501.327.1222 x254 from the hours of 8:30AM-5:00PM central time Monday-Friday, or e-mail at questions@uscompounding.com to discuss the return of any unused sterile compounded products.”

Source: FDA