Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
National Drug Code
Is NDC 54482-0020-01 recalled?
Cystaran
Yes — this exact package was recalled
3 FDA recalls name the code 54482-0020-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- cysteamine hydrochloride
- Strength
- CYSTEAMINE HYDROCHLORIDE 6.5 mg/mL
- Form
- Solution · Ophthalmic
- Labeler
- Leadiant Biosciences, Inc.
- Type
- Human Prescription Drug
- Product code
- 54482-0020
Recalls naming this package
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.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 54482-0301 See recall 1
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