MEGA-BURN 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@28, 5/31/2015; 04152015@17, 7/14/2015; 04152015@44, 7/14/2015; 02272015@62, 5/28/2015; 03032015@25, 6/1/2015; 03122015@89, 6/10/2015; 03162015@58, 6/14/2015; 03182015@28, 6/16/2015; 03302015@26, 6/28/2015; 04062015@65, 7/5/2015; 04142015@45, 7/13/2015; 04172015@46, 7/16/2015; 04242015@27, 7/23/2015; 04292015@31, 7/28/2015; 04292015@81, 7/28/2015; 5082015@63, 8/6/2015; 04302015@9, 7/29/2015; 05112015@30, 8/9/2015; 5072015@14, 8/5/2015

Distribution pattern: Nationwide