Bromfenac Ophthalmic Solution 0 — Class II drug recall D-0009-2016
Terminated recall by Apotex Inc., reported 2015-10-21, distributed nationwide. Lack of Assurance of Sterility: Failed preservative effectiveness testing
| Recall number | D-0009-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., Toronto, N/A, Canada |
| Recall initiated | 2015-08-25 |
| Classified | 2015-10-09 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2022-06-15 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 60505-0595-05, 60505-0596-04 |
| Expiration dates | 2016-07 |
Product
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
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-0009-2016. 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.