Leadiant Recalls Subpotent Cystaran Ophthalmic Solution
Leadiant Biosciences is recalling 3,398 bottles of Cystaran ophthalmic solution because the active ingredient was below the required specification.
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 fits the criteria for a moderate severity score involving low-risk issues or voluntary precautionary actions.
Plain-English summary
Leadiant Biosciences, Inc. is recalling 3,398 bottles of Cystaran (cysteamine hydrochloride) 0.44% ophthalmic solution. The product is a prescription-only eye drop manufactured by Hi-Tech Pharmacal Co. Inc. for Leadiant Biosciences, Inc.
The recall was initiated because the product was found to be subpotent, meaning it was out of specification for the active ingredient cysteamine hydrochloride. The affected lots are 35866 (expiration 6/18) and 358663 (expiration 7/18).
The recalled product was distributed to Walgreens Specialty Pharmacy in Pittsburg, PA, as well as to Italy and Germany. Patients who have this medication should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- CYSTARAN (CYSTEAMINE HYDROCHLORIDE)
- Brand
- CYSTARAN
- Manufacturer
- LEADIANT BIOSCIENCES, INC
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 3,398
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 (4)
- lot numbers: 35866
- Exp 6/18
- 358663
- Exp 7/18
Distribution
Distribution scope not specified by the agency.
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