Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, P...
FDA Recall #D-0426-2017 — Class III — October 12, 2016
Product Description
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
Reason for Recall
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Recalling Firm
Pharm D Solutions, LLC — Houston, TX
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4 mL: 510 vials, 5 mL: 486 vials
Distribution
AZ and WA
Code Information
Lot: 09122016:34, exp 09/07/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated