Product: Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: 20130502
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated