Leadiant Biosciences, Inc. recalls Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured
Recalled October 21, 2020 · FDA recall D-0034-2021 · Leadiant Biosciences
Hazard
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl. · FDA Class III
Units
1380 bottles
Sold at
PA and Italy
Description
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Product
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
Manufacturer(s)
Leadiant Biosciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →