Drug product
HCG liquid, 1000u/ml, RX, glass vial, various
D-0395-2019
Product summary
- Event
- Event 81883
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 ml
- Official record key
drug-enforcement:D-0395-2019
Official wording
Reason: Lack of sterility assurance.
Code information: 10162018@22
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