The Harvard Drug Group LLC, doing business as Major Pharmaceuticals and Rugby Laboratories, is recalling 1,337,690 bottles of Rugby brand eye drops. The recall includes Polyvinyl Alcohol 1.4% Lubricating Eye Drops and Lubricating Tears (Dextran/Hypromellose 0.1%/0.3%) formulas. This action was taken after FDA environmental sampling at the manufacturing facility revealed insanitary conditions and positive bacterial test results.
Using non-sterile eye drops contaminated with bacteria can lead to serious eye infections, which may result in permanent vision loss or other severe complications. No injuries have been reported to date.
You have 2 options:
Polyvinyl Alcohol, 1.4% Lubricating Eye Drops, Carton label
Polyvinyl Alcohol, 1.4% Lubricating Eye Drops, Bottle label
Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%), Carton Label
Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%), Bottle Label
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 · FDA Press Release (1) · FDA Press Release (2) · 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.