FDA-Drug2020-10-21Class III
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
Leadiant Biosciences, Inc.
Hazard
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Sold states
PA and Italy
Affected count
1380 bottles
Manufactured in
9841 Washingtonian Blvd Ste 500, N/A, Gaithersburg, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0034-2021Don't want to check this manually?
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