FDA recall D-0804-2021
Prescription Labs Inc dba Greenpark · Class II · drug
Product
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2021-08-18
- Report date
- 2021-09-22
- Termination date
- 2023-08-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Houston, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0804-2021