Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration,
Recall Number: D-455-2013
Firm: Nora Apothecary and Alternative Therapies, Inc.
Classification: Class II
Status: Terminated
Report Date: 20130605
Initiation Date: 20130422
Termination Date: 20140801
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product Description
Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration,