OFLOXACIN
Generic: OFLOXACIN
Somerset TherapeuticsManufacturer
OPHTHALMICRoute
OFLOXACINActive Substance
2024-08-01Original Approval
OFLOXACIN is FDA application ANDA213597, sponsored by SOMERSET. 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 II2022-04-13
Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3cGMP deviations: Temperature abuse
Class II2019-07-02
Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05Lack of Assurance of Sterility
Top Reported Reactions
1
EYE PAIN
342 reports
2
DRUG INEFFECTIVE
333 reports
3
OFF LABEL USE
306 reports
4
HEADACHE
273 reports
5
PAIN
258 reports
6
FATIGUE
250 reports
7
NAUSEA
249 reports
8
ARTHRALGIA
244 reports
9
ACUTE KIDNEY INJURY
241 reports
10
DIARRHOEA
233 reports