Hydromorphone 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, 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; 04212015@19, 7/20/2015; 02232015@28, 5/24/2015; 02252015@18, 5/26/2015; 03022015@12, 5/31/2015; 03302015@61, 6/28/2015; 04222015@11, 7/21/2015

Distribution pattern: Nationwide