Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, 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; 06132014@45, 6/13/2015; 02032015@82, 2/3/2016; 03242015@26, 3/23/2016; 08142014@46, 8/14/2015; 07172014@54, 7/17/2015; 12032014@77, 12/3/2015; 03102015@23, 3/9/2016; 03042015@44, 3/3/2016

Distribution pattern: Nationwide