Home / Recalls / Leadiant Biosciences, Inc. / D-0034-2021

D-0034-2021 Class III Terminated

Recalled by Leadiant Biosciences, Inc. — Gaithersburg, MD

Recall Details

Product Type
Drugs
Report Date
October 21, 2020
Initiation Date
September 24, 2020
Termination Date
November 10, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1380 bottles

Product Description

Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01

Reason for Recall

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

Distribution Pattern

PA and Italy

Code Information

Lot #: 370655, Exp. 10/31/2020

Other recalls by Leadiant Biosciences, Inc.

  • D-0327-2023 Class II — Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, (February 3, 2023)
  • 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)