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

Recalled March 7, 2018 · FDA recall D-0550-2018 · LEADIANT BIOSCIENCES

Hazard

Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. · FDA Class III

Units

1,705 bottles

Sold at

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

Description

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

Product

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

Manufacturer(s)

LEADIANT BIOSCIENCES, INC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →