What eye drops are contaminated? FDA expands warning recall list 

Consumers and health care professionals across the country are hereby warned by the FDA to stop using Delsam Pharma’s Artificial Eye Ointment as it could be linked to potential microbial contamination.

The United States Food & Drug Administration (FDA) is expanding a previously announced eye-drop recall to include the Delsam Pharma’s Artificial Eye Ointment, along with the previously recalled EzriCare Artificial Tears, and Delsam Pharma’s Artificial Tears. The affected products could be contaminated with a “rare, extensively drug-resistant” Pseudomonas aeruginosa bacteria, which poses a risk of eye infections and could result in permanent blindness.

While the previous recall announced on February 2 was for EzriCare's Artificial Tears Eyedrops, the recall expansion is for Delsam Pharma's Artificial Eye Ointment. The over-the-counter products may be related to eye infection outbreaks earlier this year that left over 16 people in hospitals.

Out of the 16 people, at least one of the patients succumbed to death, while at least five of them suffered permanent vision loss from the use of the bacteria infected over-the-counter (OTC) eyedrops.

outer packaging of the Delsam Pharma’s Artificial Eye Ointment recalled by FDA (Image via Delsam Pharma/FDA)

The manufacturer of both the over-the-counter products, Global Pharma Healthcare Private Limited, has agreed to recall Delsam Pharma’s Artificial Eye Ointment. As of now, all known stocks of the product are being removed from store shelves and pharmacies across the country. Consumers and health professionals are advised not to take this recall lightly as the risk of suffering a permanently incurable medical problem may be much higher in this case.

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FDA expands the eye drop recall to include the Delsam Pharma’s Artificial Eye Ointment

The recall affects all stocks of Delsam Pharma’s Artificial Eye Ointment, which is manufactured by Global Pharma Healthcare Private Limited. Pharmacy chains, Costco Warehouses, and other retailers across the nation sold the affected goods, which were widely available. Customers could have also purchased the recalled products from online retailers like Amazon and more.

The recalled Artificial Eye Ointment was packed in tubes that were distributed to retail channels across the country in labeled paper boxes. Customers can recognize the recalled products by checking for details - Delsam Pharma’s NDC 72570-121-15, UPC 3 72570 12115 - printed on the boxes and/or the tube.

the recalled Delsam Pharma’s Artificial Eye Ointment (Image via FDA)

Customers who may have purchased the recalled products are strictly advised not to use them and to dispose of them safely in a closed bin. The contaminated ointments should not be used on your eyes or anyone else's eyes because they can cause severe eye infections and permanent vision loss. The symptoms of an eye infection include pain in the eyes, swelling, discharge, redness, blurry vision, sensitivity to light, and the feeling of foreign objects stuck in the eye.

A patient experiencing any of the aforementioned symptoms following the usage of recalled products should seek medical attention to see if it's caused by the Pseudomonas aeruginosa bacterium. Those who may have doubts or queries regarding the FDA recall expansion can get in touch with DELSAM Pharma LLC by phone at 1-866-826-1306, Monday to Friday, 11 am to 4 pm EST. The company is also reachable via emails sent to - [email protected].