Drug product
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0433-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 3 ml bottles
- Official record key
drug-enforcement:D-0433-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 11052018@4 BUD: 1/18/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility