D-0396-2019 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
- 20 ml
Product Description
Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial
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
10252018@24