LEADIANT BIOSCIENCES, INC

FDA Regulatory Profile

LEADIANT BIOSCIENCES, INC appears in FDA public data with 4 recalls, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (D-0327-2023, Class II) was initiated on February 3, 2023.

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0327-2023Class IIAbelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by ExeFebruary 3, 2023
D-0034-2021Class IIICystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx September 24, 2020
D-0683-2018Class IIICystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech PharApril 9, 2018
D-0550-2018Class IIICystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech PharFebruary 14, 2018