March 28, 2023

FDA Issues Extended Cautionary Notice Regarding Eye Products Over Potential Contamination

The Food and Drug Administration  has issued a warning regarding potential contamination in artificial tears products, causing concern among healthcare professionals and consumers. This warning was issued after the FDA discovered multiple violations in the manufacturing process of artificial tears products by Delsam Pharma, which is owned by Global Pharma Healthcare Private Limited. As a result, Global Pharma Healthcare Private Limited has voluntarily recalled all lots within expiry of its Artificial Tears Lubricant Eye Drops that were distributed by EzriCare, LLC and Delsam Pharma. This recall was issued to the consumer level, as there is a potential risk of bacterial contamination.

The FDA’s warning is particularly concerning in light of the recent outbreak of a “rare, extensively drug-resistant” Pseudomonas aeruginosa bacteria in a dozen states, which had never before been seen in the U.S. This outbreak has heightened concerns over the safety and efficacy of over-the-counter eye products, prompting the FDA to issue a warning to protect the public. Artificial tears are a common over-the-counter remedy for dry eyes and other eye conditions. While these products are generally considered safe, the manufacturing process can introduce contaminants that can lead to infection and other adverse effects.

It is important to note that the FDA’s warning specifically targets Delsam Pharma’s artificial tears products, but it serves as a reminder that all eye products should be used with caution. If you experience any adverse effects after using an eye product, you should stop using it immediately and consult with your eye doctor or healthcare provider. Additionally, it is important to follow the instructions for use carefully when using any eye product. This includes washing your hands before and after use, avoiding touching the tip of the dropper or applicator to your eye, and not sharing your eye product with others.

The recent recalls and warnings issued by the FDA highlight the importance of proper manufacturing and quality control when it comes to over-the-counter eye products. Consumers should be able to trust that the products they purchase are safe and effective, and it is the responsibility of manufacturers and regulators to ensure that this is the case. In light of these recent events, it is important to remain vigilant and informed when it comes to eye health and the products we use to maintain it. Regular eye exams, proper hygiene, and careful use of eye products can help to prevent eye infections and other adverse effects.

In conclusion, the recent FDA warnings and recalls serve as a reminder of the importance of proper manufacturing and quality control when it comes to over-the-counter eye products. As consumers, it is our responsibility to remain informed and vigilant when it comes to our eye health, and to take necessary precautions to protect ourselves from potential harm. If you have been using any of the recalled products, it is important to stop using them immediately and dispose of them properly. Additionally, if you have experienced any adverse effects from using the product, it is important to report it to the FDA’s MedWatch program.