Approximately 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution (USP, 2.5%, 15 mL), a prescription medication used for eye exams and procedures, have been recalled. The product failed testing intended to ensure the container remains sealed and sterile, meaning the sterility of the drops cannot be guaranteed. This recall affects one specific lot of bottles distributed nationwide in the USA and Puerto Rico. Consumers should stop using the affected lot immediately to avoid potential contamination risks.
A failure in the container's closure system means that the medicine may not remain sterile and could become contaminated with microorganisms. Using non-sterile eye drops can lead to serious eye infections, which in some cases may result in permanent vision damage.
Healthcare provider consultation and pharmacy refund.
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 · 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.