Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04

Recall Number: D-0426-2017

Firm: Pharm D Solutions, LLC

Classification: Class III

Status: Terminated

Report Date: 20170118

Initiation Date: 20161012

Termination Date: 20170511

Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct

Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04