Leadiant Biosciences, Inc. recalls Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured…

Recall date

September 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0034-2021

FDA classification

Class III

Brand / firm

Leadiant Biosciences, Inc.

Sold / distributed

PA and Italy

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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