Bromfenac ophthalmic recalls
The FDA has published 4 recalls involving Bromfenac ophthalmic since 2015. The latest was reported on 27 Jan 2016. Most were for sterility. Apotex has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls4since 2015
Last 12 months0reported
Class I00% of total
Ongoing0latest 27 Jan 2016
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 75%Class III 1 25%
Why bromfenac ophthalmic is recalled
Companies
By year
All bromfenac ophthalmic recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bromfenac Ophthalmic Solution 09%, a) bottles recalled by Mayne Pharma U | Mayne Pharma U | Sterility | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Apotex | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Bausch & Lomb | Bausch & Lomb | Sterility | Nationwide |
| Drug | CLASS III | Bromfenac Ophthalmic Solution recalled by Apotex | Apotex | Manufacturing (CGMP) Deviations | Nationwide |
Should you stop taking Bromfenac ophthalmic?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.