Drug recall
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated…
FDA recall event 71896 · Class II · Bausch & Lomb, Inc.
Key facts
| Event ID | 71896 |
|---|---|
| Recall numbers | D-1349-2015 |
| Recalling firm | Bausch & Lomb, Inc. |
| Product type | Drugs |
| Products | Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Failed preservative effectiveness testing. |
| Initiation date | Aug 17, 2015 |
| Report date | Aug 26, 2015 |
| Termination date | Apr 7, 2017 |
| City | Tampa |
| State | FL |
| Country | United States |
| FEI number | 1000113778 |
At a glance
- 1–9 Products in this recall
- 10–99 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: