Product: Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml  Penile Injection, 30 and 90 day expiration,
Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Recall initiated: 20130422
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated