MEGA-BURN* 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@61, 5/31/2015; 03052015@11, 6/3/2015; 04132015@21, 7/12/2015; 03242015@7, 6/22/2015; 04292015@11, 7/28/2015

Distribution pattern: Nationwide