FLUORESCEIN

Generic: FLUORESCEIN

Zydus Pharmaceuticals USA Inc.Manufacturer
INTRAVENOUSRoute
FLUORESCEIN SODIUMActive Substance
2026-06-01Original Approval

FLUORESCEIN is FDA application ANDA218651, sponsored by ZYDUS LIFESCIENCES. 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 II2019-07-02
Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only

Lack of Assurance of Sterility

Class II2025-12-31
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, N

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good

Top Reported Reactions

1
PRURITUS
59 reports
2
VISUAL ACUITY REDUCED
46 reports
3
NAUSEA
40 reports
4
RASH
36 reports
5
DIZZINESS
34 reports
6
ANAPHYLACTIC SHOCK
31 reports
7
VOMITING
28 reports
8
URTICARIA
26 reports
9
DYSPNOEA
25 reports
10
ANAPHYLACTIC REACTION
23 reports