LOTEPREDNOL ETABONATE

Generic: LOTEPREDNOL ETABONATE

Bausch & Lomb Americas Inc.Manufacturer
OPHTHALMICRoute
LOTEPREDNOL ETABONATEActive Substance
1998-03-09Original Approval

LOTEPREDNOL ETABONATE is FDA application NDA020583, sponsored by BAUSCH AND LOMB. 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 III2019-06-17
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pha

Failed Stability Specifications: Out of specification for viscosity.

Top Reported Reactions

1
EYE PAIN
588 reports
2
EYE IRRITATION
489 reports
3
OFF LABEL USE
360 reports
4
VISION BLURRED
353 reports
5
DRUG INEFFECTIVE
331 reports
6
OCULAR HYPERAEMIA
280 reports
7
HEADACHE
229 reports
8
FATIGUE
213 reports
9
DRY EYE
181 reports
10
PAIN
176 reports