Sun Pharmaceutical Industries Inc. has voluntarily recalled 69,707 cartons of Cequa (cyclosporine ophthalmic solution) 0.09% because testing showed the medication is subpotent. This means the drug may not have the required strength of the active ingredient to be fully effective for its intended use. The recall affects 60-count cartons of single-use vials with lot numbers 10026 and 10027. No incidents or injuries related to this recall have been reported at this time.
Using a subpotent ophthalmic solution may result in reduced effectiveness of the medication for the treatment of dry eye symptoms. Patients using these specific lots may not receive the full therapeutic benefit intended by their prescription.
You have 2 options:
Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France.
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.