D-0392-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 9, 2019
- Initiation Date
- January 2, 2019
- Termination Date
- March 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 830 ml
Product Description
Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
Reason for Recall
Lack of sterility assurance.
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.
Code Information
08172018@7 exp 2/13/19, 09202018@16 exp 3/2/19, 10172018@32 exp 3/2/19.