Class II · Moderate risk Ongoing
Bromfenac Ophthalmic Solution 0.09%
Reason Failed Impurities/Degradation Specifications
Bromfenac Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
What was recalled
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
- Recalling firm
- Bausch & Lomb, Inc.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1349-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Bromfenac recalls
See all
Class II · Moderate risk Ongoing
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile…
Reason Subpotent Drug
Class III · Low risk Terminated
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%
Reason Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class II · Moderate risk Terminated
Bromfenac Ophthalmic Solution 0.09% 1.7ml Ndc/Upc 62332-508-17
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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