Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, 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-0683-2018

Firm: LEADIANT BIOSCIENCES, INC

Classification: Class III

Status: Terminated

Report Date: 20180425

Initiation Date: 20180409

Termination Date: 20181129

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

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