Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527

Recall Number: D-0006-2016

Firm: Diabetes Corporation of America dba DCA Pharmacy

Classification: Class II

Status: Terminated

Report Date: 20151014

Initiation Date: 20150923

Termination Date: 20160112

Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.

Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527