Drug product
TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
D-1525-2022
Product summary
- Event
- Event 90798
- Status
- Completed
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-1525-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 07052022@1 BUD: 10/08/2022
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility