Akorn, Inc. is recalling approximately 31,812 bottles of Atropine Sulfate Ophthalmic 1% Solution, a prescription eye medication used to dilate the pupil. The recall was issued because laboratory testing of retained samples showed the liquid's thickness (viscosity) was lower than required by quality specifications. This defect could potentially impact how the medication is dispensed from the bottle or how it adheres to the eye during treatment.
Low viscosity results mean the medication is thinner than intended, which can alter the drop size and the rate at which the drug is absorbed or cleared from the ocular surface, potentially affecting the medication's effectiveness.
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.