LEADIANT BIOSCIENCES, INC recalls Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amity
Recalled April 25, 2018 · FDA recall D-0683-2018 · LEADIANT BIOSCIENCES
Hazard
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. · FDA Class III
Units
3,398 bottles
Sold at
Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
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 →