D-0398-2019 Class II Terminated
FDA drug recall D-0398-2019 was initiated by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy on January 2, 2019 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated March 28, 2023). Affected quantity: 50 ml.
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
- 50 ml
Product Description
Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments
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
08072018@30