Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., 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; 12012014@59, 5/30/2015; 01122015@34, 7/11/2015; 02102015@42, 7/1/2015; 03162015@12, 9/12/2015; 04282015@59, 10/25/2015; 05052015@65, 11/1/2015

Distribution pattern: Nationwide