Bromfenac Ophthalmic Solution 0 — Class II drug recall D-0585-2016
Terminated recall by Mayne Pharma Usa, reported 2016-01-27, distributed nationwide. Lack of Assurance of Sterility: Failed preservative effectiveness test
| Recall number | D-0585-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mayne Pharma Usa, Greenville, NC, United States |
| Recall initiated | 2016-01-05 |
| Classified | 2016-01-20 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2017-01-13 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 00378-7109-35, 00378-7110-35 |
| Lot numbers | 0378-7109-35, 0378-7110-35, AC2328, AC2330, AC6330, AC7894, AD2527, AD4515, AD4819 |
| Expiration dates | 2016-01, 2016-04, 2016-05, 2016-06, 2016-08 |
Product
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
Reason for recall
Lack of Assurance of Sterility: Failed preservative effectiveness test
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-0585-2016. 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.