Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Cystaran (cysteamine ophthalmic solution) (Cysteamine Hydrochloride)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
54482-0020-01
Compare with the code on your package — it is the most precise check available.
Drug: Cysteamine Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cystaran cysteamine hydrochloride NDC 54482-0020 |
6.5 mg/mL | Solution Ophthalmic |
Leadiant Biosciences, Inc. | Rx |
- Recalling firm
- Leadiant Biosciences, Inc.
- NDC code
- 54482-020-01
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0034-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cysteamine recalls
See all
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Other recalls by Leadiant Biosciences, Inc.
All 2020 recalls
Class II · Moderate risk
Abelcet (Amphotericin B Lipid Complex)
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Other wrong potency / content recalls from 2020
All wrong potency / content recalls
Class II · Moderate risk
Class II · Moderate risk
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Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Class II · Moderate risk
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Subpotent drug
Class II · Moderate risk
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