Leadiant Biosciences, Inc.
NDC labeler code: 54482
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- LevocarnitineCarnitor, Carnitor Sf · 4 products
- Cysteamine hydrochlorideCystaran, Cystadrops · 2 products
- Procarbazine hydrochlorideMatulane · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| October 2, 2012 | NDA200740 | Cysteamine hydrochloride CYSTARAN | Leadiant Biosci Inc |
| December 16, 1992 | NDA020182 | Levocarnitine CARNITOR | Leadiant Biosci Inc |
| April 10, 1986 | NDA019257 | Levocarnitine CARNITOR, CARNITOR SF | Leadiant Biosci Inc |
| December 27, 1985 | NDA018948 | Levocarnitine CARNITOR | Leadiant Biosci Inc |
| July 22, 1969 | NDA016785 | Procarbazine hydrochloride MATULANE | Leadiant Biosci Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2020
-
September 24, 2020 · Class III · Terminated · D-0034-2021 · Cysteamine hydrochloride
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
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 2
2018
-
April 9, 2018 · Class III · Terminated · D-0683-2018 · Cysteamine hydrochloride
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
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
-
February 14, 2018 · Class III · Terminated · D-0550-2018 · Cysteamine hydrochloride
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
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
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026