Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Refrigerate, 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; 10222014@55, 10/22/2015; 10032014@43, 10/3/2015; 12012014@42, 12/1/2015; 01092015@35, 1/9/2016; 02022015@52, 2/2/2016; 02232015@78, 2/23/2016; 03122015@81, 3/11/2016; 03312015@38, 3/30/2016

Distribution pattern: Nationwide