Drug product
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
D-0434-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 250 3 ml bottles
- Official record key
drug-enforcement:D-0434-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 09262018@5 BUD: 1/15/2019; 10092018@1 BUD: 1/25/2019; 11052018@1 BUD: 2/21/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility