FDA Drug recall D-0585-2016
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 Pharmaceu…
- FDA Drug
- Class II
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class II recall of 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 Pharmaceu… by Mayne Pharma Usa, citing lack of Assurance of Sterility: Failed preservative effectiveness test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0585-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-05 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mayne Pharma Usa |
| Distribution | US |
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
Lack of Assurance of Sterility: Failed preservative effectiveness test
Identifiers
| code_info | a) Lot numbers: 0378-7110-35 AD4819, Exp. Date: 08-2016; 0378-7110-35 AC7894, Exp. Date: 05-2016; 0378-7110-35 AD2527,…a) Lot numbers: 0378-7110-35 AD4819, Exp. Date: 08-2016; 0378-7110-35 AC7894, Exp. Date: 05-2016; 0378-7110-35 AD2527, Exp. Date: 06-2016; 0378-7110-35 AC6330, Exp. Date: 05-2016; 0378-7110-35 AC2330, Exp. Date: 04-2016 and b) Lot numbers: 0378-7109-35 AD4515, Exp. Date: 04-2016 and 0378-7109-35 AC2328, Exp. Date: 01-2016. |
|---|
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-0585-2016%22
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