Leadiant Recalls Subpotent Cystaran Ophthalmic Solution
Leadiant Biosciences is recalling 1,380 bottles of Cystaran ophthalmic solution because testing found decreased levels of the active ingredient.
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 indicates the product is unlikely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct safety hazard like contamination or injury.
Plain-English summary
Leadiant Biosciences, Inc. is recalling 1,380 bottles of Cystaran (cysteamine hydrochloride) 0.44% ophthalmic solution. The recall was initiated because product testing identified a decreased level of the active ingredient, Cysteamine HCl, making the product subpotent.
The affected product is Lot #370655 with an expiration date of 10/31/2020. The bottles are 15 mL, sterile, and labeled for ophthalmic use only. The product was distributed in Pennsylvania and Italy.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- CYSTARAN (CYSTEAMINE HYDROCHLORIDE)
- Brand
- CYSTARAN
- Manufacturer
- Leadiant Biosciences, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 1,380
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 #: 370655
- Exp. 10/31/2020
Distribution
Distribution scope not specified by the agency.
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