Approximately 1,705 bottles of Cystaran (cysteamine ophthalmic solution) 0.44% have been voluntarily recalled because the medication was found to be subpotent. Testing showed that the drug was out of specification for its active ingredient, cysteamine hydrochloride, meaning it may not provide the full therapeutic effect required for patients. This medication is used to treat rare eye conditions and was distributed to a single specialty pharmacy in Pennsylvania and accounts in Italy. If you are using this medication, you should contact your healthcare provider or pharmacist to discuss your treatment.
The drug contains less than the required amount of the active ingredient cysteamine hydrochloride. This subpotency could result in the medication being less effective at treating the patient's underlying condition.
Healthcare provider consultation and pharmacy return
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.