Drug product
Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
D-0392-2019
Product summary
- Event
- Event 81883
- Status
- Terminated
- Classification
- Class II
- Quantity
- 830 ml
- Official record key
drug-enforcement:D-0392-2019
Official wording
Reason: Lack of sterility assurance.
Code information: 08172018@7 exp 2/13/19, 09202018@16 exp 3/2/19, 10172018@32 exp 3/2/19.
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