(NewsNation) — The Food and Drug Administration is warning consumers not to use certain eye products, including EzriCare and Delsam Pharma’s Artificial Tears, because of potential contamination.
The FDA put out its original warning Feb. 2 for the Artificial Tears, but expanded that Tuesday to include Delsam Pharma’s Artificial Eye Ointment, as well. Delsam Pharma’s Artificial Eye Ointment is an over-the-counter product.
All of these products are manufactured by Global Pharma Healthcare Private Limited.
Global Pharma initiated a voluntary recall of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears after the FDA recommended it because of the company’s current good manufacturing practice violations. These included a lack of appropriate microbial testing, formulation issues, and lack of proper controls surrounding tamper-evident packaging.
Delsam Pharma told CBS News it plans to recall its eye ointment, too.
Global Pharma Health Care Private Limited is on an import alert for giving an “inadequate response to a records request and for not complying with CGMP requirements.” The import alert prevents these products from entering the U.S., according to the FDA.
NewsNation reached out to Global Pharma for comment.
“Using contaminated artificial tears increases the risk of eye infections that could result in blindness or death,” the FDA said. “Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately.”
Dr. Dave Montgomery, the host of “The Good Doctor TV,” said just because a product is natural, doesn’t mean it’s risk-free, and just because it’s over the counter doesn’t mean it’s for you. He said that it is important to have a conversation with the doctor to get the best-prescribed medication for oneself.
Peter Pitts, former associate commissioner of the FDA, highlighted the manufacturing company’s noncompliance with regulations and called on the agency, as well as the Centers for Disease Control and Prevention, to improve communication with the public.
“These are bad players,” Pitts said of the manufacturing company.
“Shame on us for letting it reach this point where people die and go blind because the appropriate actions on the part of our agencies from a communications perspective hasn’t really taken place,” he added.
This comes after the CDC identified 55 patients in 12 states with infections linked to EzriCare Artificial Tears. One death with bloodstream infection was reported, as well as other adverse events, including hospitalization and permanent vision loss from eye infections.
The FDA and CDC are now investigating a multistate outbreak of pseudomonas aeruginosa bacteria. Nexstar Media Wire reports that pseudomonas aeruginosa bacteria can cause infections in the blood, lungs and other body parts, often after surgery.
Those experiencing quality problems with any medicine can report it to FDA’s Medwatch online, or by downloading and completing a form that can be submitted via fax to 800-FDA-0178.
NewsNation’s Devan Markham contributed to this report.