Lipo-DEN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information: All lots distributed between November 2014 and May 2015; 03022015@26, 5/31/2015; 02272015@22, 5/28/2015; 03092015@75, 6/7/2015; 04092015@97, 7/8/2015; 04092015@37, 7/8/2015; 03022015@78, 5/31/2015; 04102015@6, 7/9/2015; 04242015@31, 7/23/2015

Distribution pattern: Nationwide