Home / Recalls / Leadiant Biosciences, Inc. / D-0327-2023

D-0327-2023 Class II Terminated

Recalled by Leadiant Biosciences, Inc. — Gaithersburg, MD

Recall Details

Product Type
Drugs
Report Date
February 22, 2023
Initiation Date
February 3, 2023
Termination Date
September 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31,879 vials

Product Description

Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41

Reason for Recall

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

Distribution Pattern

Nationwide USA

Code Information

Lot#: 1203A, Exp. 5/11/2024

Other recalls by Leadiant Biosciences, Inc.

  • D-0034-2021 Class III — Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL (September 24, 2020)
  • D-0683-2018 Class III — Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufact (April 9, 2018)
  • D-0550-2018 Class III — Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufact (February 14, 2018)