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

Recall Number: D-0034-2021

Firm: Leadiant Biosciences, Inc.

Classification: Class III

Status: Terminated

Report Date: 20201021

Initiation Date: 20200924

Termination Date: 20211110

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

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