FDC Limited is recalling approximately 60,428 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5% (10mL), a prescription medication used to treat high pressure in the eye. The recall was initiated because the spike inside the bottle cap can become stuck in the nozzle, preventing the solution from being dispensed. This defect may cause patients to miss their prescribed doses.
If the nozzle is blocked, the patient cannot dispense the medication, which can lead to poorly controlled eye pressure and potential progression of eye conditions like glaucoma. No injuries have been reported to date.
You have 2 options:
Distributed by Rising Pharmaceuticals Inc, New Jersey. Manufactured by FDC Limited, Waluj, Aurangabad, India.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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 ยท 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.