Leadiant Recalls Subpotent Cystaran Cysteamine Ophthalmic Solution
Leadiant Biosciences is recalling 1,705 bottles of Cystaran ophthalmic solution because the active ingredient was below the required strength.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2. A score of 2 is assigned because the product is subpotent (lacking full efficacy), which is a functional defect rather than a cosmetic or documentation-only issue, but it is not likely to cause adverse health consequences.
Plain-English summary
Leadiant Biosciences, Inc. is recalling 1,705 bottles of Cystaran (cysteamine hydrochloride) 0.44% ophthalmic solution. The recall was initiated because the product was found to be subpotent, meaning it did not contain the required amount of the active ingredient, cysteamine hydrochloride.
The affected product is identified by Lot # 356075 and an expiration date of 2/28/18. The product was distributed to one specialty pharmacy distributor in the US, Walgreens Specialty Pharmacy, and to a foreign account in Italy.
Patients who have received this product should contact their healthcare provider for further instructions. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- CYSTARAN (CYSTEAMINE HYDROCHLORIDE)
- Brand
- CYSTARAN
- Manufacturer
- LEADIANT BIOSCIENCES, INC
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 1,705
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 356075
- Exp 2/28/18
Distribution
Distribution scope not specified by the agency.
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