FDA Drug recall D-1349-2015
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class II recall of Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only by Bausch And Lomb, citing lack of Assurance of Sterility: Failed preservative effectiveness testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1349-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-17 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bausch And Lomb |
| Distribution | US |
Product
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
Reason
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Identifiers
| code_info | Lot #221211, Expiry: 09/30/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1349-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.