DrugFeb 22, 2023
Leadiant Biosciences Abelcet recall — FDA D-0327-2023
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Class IIFDA: TerminatedLeadiant Biosciences, Inc.
Recall history in this database
Classification mix: Class III: 3, Class II: 1.
DrugOct 21, 2020
Cystaran recall — FDA D-0034-2021
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Class IIIFDA: TerminatedLeadiant Biosciences, Inc.
DrugApr 25, 2018
Cystaran recall — FDA D-0683-2018
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class IIIFDA: TerminatedLEADIANT BIOSCIENCES, Inc.
DrugMar 7, 2018
Cystaran recall — FDA D-0550-2018
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class IIIFDA: TerminatedLEADIANT BIOSCIENCES, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Leadiant Biosciences, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.