BROMFENAC
Generic: BROMFENAC
Aurobindo Pharma LimitedManufacturer
OPHTHALMICRoute
BROMFENAC SODIUMActive Substance
2022-03-18Original Approval
BROMFENAC is FDA application ANDA204813, sponsored by EUGIA PHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2025-05-07
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., BFailed Impurities/Degradation Specifications
Class II2021-03-15
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPSCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
TREATMENT FAILURE
147 reports
2
DRUG INEFFECTIVE
66 reports
3
EYE PAIN
44 reports
4
VISUAL IMPAIRMENT
32 reports
5
FATIGUE
31 reports
6
PRODUCT DOSE OMISSION ISSUE
31 reports
7
CATARACT
30 reports
8
OFF LABEL USE
28 reports
9
EYE IRRITATION
27 reports
10
NAUSEA
27 reports