The Centers for Disease Control and Prevention is issuing another alert related to eye drops in connection with a recent outbreak of drug-resistant infection.
Officials are concerned potentially deadly bacteria will spread and cases could be reported in the coming weeks and months, and health inspectors revealed this week that the eye drop maker has failed to take steps to ensure sterility at its factory in India.
In a video, CDC epidemiologist Maroya Walters said people should stop using recalled eye products related to an outbreak of Pseudomonas aeruginosa immediately. The recalled products are EzriCare Artificial Tears, Delsam Pharma Artificial Tears and Delsam Pharma Artificial Eye Ointment. All eye products are manufactured by India-based Global Pharma Healthcare Private Ltd. imported.
Food and Drug Administration officials uncovered about a dozen problems with how Global Pharma Healthcare made and tested its eye drops during an inspection from late February to early March. The FDA released its preliminary inspection report on Monday.
The company uses procedures that cannot truly ensure its products are sterile, FDA officials wrote. Specifically, inspectors found that between December 2020 and April 2022, the plant had used “a deficient manufacturing process” on products that were later shipped to the United States
A rare strain of Pseudomonas aeruginosa has been diagnosed in 68 patients across 16 states. 37 of the patients were affiliated with four healthcare facilities. Three people have died – an increase of two from February’s report – and there have been eight reports of vision loss and four reports of patients having their eyeballs surgically removed.
The outbreak linked to the plant in the southern state of Tamil Nadu is considered of particular concern because the bacteria powering it are resistant to standard antibiotics.
Inspectors arrived at the facility on February 20, more than two weeks after the February 3 announcement of the first eyedrop recall. The inspection appears to be FDA’s first visit to the facility, according to agency records.
This image provided by Global Pharma Healthcare shows the packaging of their Artificial Tears eye drop product, which is distributed by Delsam Pharma. Don’t use this product, the CDC warned. (Global Pharma Healthcare via AP)
The report contains the agency’s preliminary findings and will likely be followed by a formal report and warning letter to the company. An FDA spokesman said the inspection showed the company’s products “potentially violate FDA requirements.”
“We urge consumers to stop using these products that could harm their health,” the FDA’s Jeremy Khan wrote in an emailed statement.
The FDA is responsible for ensuring the safety of foreign products shipped to the US, although it has long struggled to keep up with international pharmaceutical supply chains, which increasingly start in India and China.
FDA inspectors cited worrisome sanitary conditions at the Global Pharma facility, noting that floors, walls and ceilings were not “easily cleaned.” At one point during the visit, an FDA inspector noted that “no filling machine equipment was wrapped or covered.” The inspector also found that the company did not have strict procedures in place to ensure bottles were fully sealed. Instead, a “manual visual inspection is the only test to detect a leak,” the report says.
Global Pharma has said little publicly about its recent recalls, instead directing questions at the US companies that sold the products.
The FDA has been investigating bacterial infections in the United States, along with the Centers for Disease Control and Prevention. CDC officials have detected the strain of bacteria in opened bottles of EzriCare drops collected from infected patients. FDA officials also test unopened bottles of the drops.
CDC officials are concerned the bacteria will spread and cases could be reported in the coming weeks and months. The agency has urged healthcare facilities treating patients to follow strict infection control recommendations because the germ can spread quickly.
This image provided by Global Pharma Healthcare shows the packaging of their product Artificial Eye Ointment, distributed by Delsam Pharma, which consumers should not use, the CDC warns. (Global Pharma Healthcare via AP)
People are advised to stop using the products and seek medical attention immediately if they have symptoms of an eye infection:
Symptoms include:
- Yellow, green, or clear discharge from the eye
- eye pain or discomfort
- Redness of the eye or eyelid
- sensation of something in the eye (foreign body sensation)
- Increased sensitivity to light
- blurred vision
–The Associated Press and al.com contributed to this report.