D-0804-2021 Class II Terminated
FDA drug recall D-0804-2021 was initiated by Prescription Labs Inc dba Greenpark on August 18, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated August 15, 2023). Affected quantity: 350 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 22, 2021
- Initiation Date
- August 18, 2021
- Termination Date
- August 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 350 bottles
Product Description
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
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