Drug product
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
D-1523-2022
Product summary
- Event
- Event 90798
- Status
- Completed
- Classification
- Class II
- Quantity
- 3 vials
- Official record key
drug-enforcement:D-1523-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 07182022@9 BUD: 10/16/2022; 07272022@15 BUD: 10/25/2022
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility