Drug product
Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
D-0437-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 167 3 ml bottles
- Official record key
drug-enforcement:D-0437-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 09262018@6 BUD: 12/25/2018; 11052018@2 BUD: 2/3/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility