TROPICAMIDE
Generic: TROPICAMIDE
Sandoz IncManufacturer
OPHTHALMICRoute
TROPICAMIDEActive Substance
1974-12-06Original Approval
TROPICAMIDE is FDA application ANDA084305, sponsored by SANDOZ. 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 III2016-01-18
Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with refer
Class III2016-01-18
Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 2420Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with refer
Top Reported Reactions
1
OFF LABEL USE
112 reports
2
VISION BLURRED
105 reports
3
EYE PAIN
91 reports
4
HEADACHE
79 reports
5
VISUAL ACUITY REDUCED
69 reports
6
DIZZINESS
62 reports
7
DRUG INEFFECTIVE
62 reports
8
VISUAL IMPAIRMENT
58 reports
9
ENDOPHTHALMITIS
54 reports
10
NAUSEA
54 reports