FDA-Drug2018-04-25Class 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
Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
Affected count
3,398 bottles
Manufactured in
9841 Washingtonian Blvd Ste 500, 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-0683-2018Don't want to check this manually?
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