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

Recall date

February 14, 2018

Source

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

Recall number

D-0550-2018

FDA classification

Class III

Brand / firm

LEADIANT BIOSCIENCES, INC

Sold / distributed

Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: Italy

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