Drug product
Cyclosporin liquid 1%, Rx, plastic dropper bottle
D-0403-2019
Product summary
- Event
- Event 81883
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0403-2019
Official wording
Reason: Lack of sterility assurance.
Code information: 07192018@12
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