Drug recall
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC…
FDA recall event 73072 · Class II · Mayne Pharma Usa
Key facts
| Event ID | 73072 |
|---|---|
| Recall numbers | D-0585-2016 |
| Recalling firm | Mayne Pharma Usa |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Failed preservative effectiveness test |
| Initiation date | Jan 5, 2016 |
| Report date | Jan 27, 2016 |
| Termination date | Jan 13, 2017 |
| City | Greenville |
| State | NC |
| Country | United States |
| FEI number | 3011142327 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: