Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,
Recall Number: D-462-2013
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
Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,