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Leadiant Biosciences, Inc.

Leadiant Biosciences, Inc. Recalls

All product recalls associated with Leadiant Biosciences, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Feb 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–4 of 4 recalls

Abelcet Injection 5 mg/mL (Leadiant Biosciences) – Sterility Concern (2023)

Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.

Class IIModerate

FDAFeb 3, 2023Nationwide• Leadiant Biosciences, Inc.

Cystaran (Leadiant Biosciences) – Subpotent Drug (2020)

Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.

Class IIILow

FDASep 24, 2020PA• Leadiant Biosciences, Inc.

Cystaran (Leadiant) – Subpotent Drug (2018)

Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.

Class III

Low

FDAApr 9, 2018PA• LEADIANT BIOSCIENCES, INC

Cystaran Eye Solution (Leadiant) – Subpotent Active Ingredient (2018)

Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.

Class IIILow

FDAFeb 14, 2018IN, PA• LEADIANT BIOSCIENCES, INC