FDA-Drug2017-01-18Class III

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

Pharm D Solutions, LLC
Hazard

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

Sold states
AZ and WA
Affected count
4 mL: 510 vials, 5 mL: 486 vials
Manufactured in
1304 S Loop W, Houston, TX, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0426-2017

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