- A drugmaker in India recalled another eye product amid a US outbreak of a drug-resistant bug.
- As of Tuesday, 58 people across 13 states had tested positive for the bug, and one person had died.
An India-based drugmaker has recalled another over-the-counter eye product in the US, amid a multistate outbreak of a rare, hard-to-treat bug initially linked to eye drops.
The US Food and Drug Administration said on Wednesday that Global Pharma followed its request to recall Delsam Pharma's Artificial Eye Ointment.
The recall came after the FDA said on February 2 that consumers and health care professionals shouldn't purchase or use EzriCare Artificial Tears, which were the first to be recalled, and Delsam Pharma's Artificial Tears.
All three products were recalled "due to potential bacterial contamination," the FDA said.
The FDA is investigating why more than fifty people in the US have tested positive for a multidrug resistant bacterium, called Pseudomonas aeruginosa, which hadn't previously been detected in the country.
Using contaminated artificial tears increases the risk of eye infections that could result in blindness or death, it said in the statement.
As of Tuesday, 58 people in 13 states (California, Colorado, Connecticut, Florida, Illinois, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington, and Wisconsin) had tested positive for the bug between May 2022 and January, according to the Centers for Disease Control and Prevention. That was up from 55 patients across 12 states in its update on February 1.
One person has died and there have been five reports of vision loss, the CDC states. Most of those cases used EzriCare Artificial Tears.
The FDA said that it had concerns around Global Pharma's manufacturing process, like a lack of appropriate testing for contamination and formulation issues — for example, the company distributes eye products in multi-use bottles without an adequate preservative. The FDA also placed a so-called "import alert" on the company on February 2 to prevent products from entering the US.
Insider has contacted Global Pharma for comment.
Eye experts say don't panic
Eye experts previously told Insider that there was no reason to panic about the news because eye infections were still relatively rare, and there were a few simple things people can do to use eye drops safely.
For example, people should use single-use preservatives-free eye drops and know the signs of an eye infection that include: eye pain, blurry vision, and discharge from the eye.
"Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately," the FDA has said.