FDA-Drug2018-03-07Class III
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
LEADIANT BIOSCIENCES, INC
Hazard
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Sold states
Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: Italy
Affected count
1,705 bottles
Manufactured in
9841 Washingtonian Blvd Ste 500, N/A, Gaithersburg, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0550-2018Don't want to check this manually?
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