Drug product
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
D-0804-2021
Product summary
- Event
- Event 88515
- Status
- Terminated
- Classification
- Class II
- Quantity
- 350 bottles
- Official record key
drug-enforcement:D-0804-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 03012021@35; 04132021@10; 05102021@12; 06012021@28; 07012021@25; 03012021@36; 04132021@12; 05102021@11; 06012021@29; 07132021@14; 03152021@9; 06162021@21; 07132021@16; 03152021@10; 06162021@22
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility