Drug product
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
D-0426-2017
Product summary
- Event
- Event 75552
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4 mL: 510 vials, 5 mL: 486 vials
- Official record key
drug-enforcement:D-0426-2017
Official wording
Reason: Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Code information: Lot: 09122016:34, exp 09/07/2017
Distribution pattern: AZ and WA
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct