Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml 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@27, 6/2062015; 02272015@42, 5/28/2015; 03112015@3, 6/9/2015; 03162015@85, 6/14/2015; 03242015@3, 6/22/2015; 03302015@63, 6/28/2015, 04062015@44, 7/5/2015; 04142015@63, 7/13/2015; 04212015@28, 6/20/2015; and 05072015@8, 7/6/2015,

Distribution pattern: Nationwide