Bromfenac Ophthalmic Solution — Class II drug recall D-1349-2015
Terminated recall by Bausch & Lomb, Inc., reported 2015-08-26, distributed nationwide. Lack of Assurance of Sterility: Failed preservative effectiveness testing.
| Recall number | D-1349-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb, Inc., Tampa, FL, United States |
| Recall initiated | 2015-08-17 |
| Classified | 2015-08-20 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2017-04-07 |
| Distributed | Nationwide (US) |
| Quantity | 13,995 bottles |
| Reason classes | sterility |
| NDC | 24208-0439-01 |
| Lot numbers | 221211 |
| Expiration dates | 2015-09-30 |
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 for recall
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1349-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.