FDA Drug recall D-0437-2019
Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy…
- FDA Drug
- Class II
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy… by Promise Pharmacy, citing lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0437-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-17 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Promise Pharmacy |
| Distribution | US |
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
Reason
Lack of sterility assurance.
Identifiers
| code_info | Lots: 09262018@6 BUD: 12/25/2018; 11052018@2 BUD: 2/3/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0437-2019%22
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