PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, 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; 02112015@31, 8/10/2015; 03132015@28, 9/9/2015; 03272015@5, 9/23/2015; 03262015@17, 9/22/2015; 03272015@17, 9/23/2015; 04012015@28, 9/28/2015

Distribution pattern: Nationwide