LOTEPREDNOL ETABONATE

Generic: LOTEPREDNOL ETABONATE

Padagis US LLCManufacturer
OPHTHALMICRoute
LOTEPREDNOL ETABONATEActive Substance
2024-07-10Original Approval

LOTEPREDNOL ETABONATE is FDA application ANDA215203, sponsored by PADAGIS US. 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 III2023-07-05
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

Top Reported Reactions

1
EYE PAIN
119 reports
2
EYE IRRITATION
78 reports
3
DRUG INEFFECTIVE
49 reports
4
OFF LABEL USE
48 reports
5
HEADACHE
41 reports
6
OCULAR HYPERAEMIA
39 reports
7
FATIGUE
38 reports
8
PHOTOPHOBIA
33 reports
9
PRODUCT DOSE OMISSION ISSUE
33 reports
10
EYE SWELLING
31 reports