LEADIANT BIOSCIENCES, INC recalls Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amit…

Recall date

April 9, 2018

Source

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

Recall number

D-0683-2018

FDA classification

Class III

Brand / firm

LEADIANT BIOSCIENCES, INC

Sold / distributed

Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany

Why it was recalled

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

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

What was recalled

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