Drug product
Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial
D-0396-2019
Product summary
- Event
- Event 81883
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 ml
- Official record key
drug-enforcement:D-0396-2019
Official wording
Reason: Lack of sterility assurance.
Code information: 10252018@24
Distribution pattern: Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Derived failure modes
-
Sterility assurance
Lack of sterility