Testosterone Cypionate 200 mg/mL in Sesame Oil recalled over undeclared excipient

Recall date

October 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pharm D Solutions, LLC recalls Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop…

Recall number

D-0426-2017

FDA classification

Class III

Brand / firm

Pharm D Solutions, LLC

Sold / distributed

AZ and WA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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