US Drug Recall Register
Class III · Low risk Terminated Initiated Oct 12, 2016 (10 years ago)

Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

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

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

Recalling firm
Pharm D Solutions, LLC
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0426-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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