DIFLUPREDNATE
Generic: DIFLUPREDNATE
Cipla USA Inc.Manufacturer
OPHTHALMICRoute
DIFLUPREDNATEActive Substance
2021-08-09Original Approval
DIFLUPREDNATE is FDA application ANDA211776, sponsored by CIPLA. 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 II2022-07-14
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies LimiteLack of Assurance of Sterility: customer complaint for defective container where breakage of the pro
Class II2022-08-02
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., IndLack of Assurance of Sterility: Complaints received of defective container closure.
Class II2022-08-22
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: CipLack of Assurance of Sterility: customer complaint for defective container where breakage of the pro
Top Reported Reactions
1
DRUG INEFFECTIVE
69 reports
2
OFF LABEL USE
56 reports
3
EYE PAIN
40 reports
4
FATIGUE
31 reports
5
DIARRHOEA
30 reports
6
HEADACHE
30 reports
7
EYE IRRITATION
29 reports
8
DECREASED APPETITE
27 reports
9
UVEITIS
25 reports
10
NAUSEA
24 reports