A drug manufacturer has recalled yet another over-the-counter eye product in the United States amid an outbreak of a rare, antibiotic-resistant bacterial outbreak that was initially linked to eye drops and artificial tears.
On Wednesday, the U.S. Food and Drug Administration (FDA) said that Global Pharma adhered to the agency’s request to recall Delsam Pharma’s Artificial Eye Ointment, an over-the-counter product.
“FDA recommended that Global Pharma recall Delsam Pharma’s Artificial Eye Ointment, and the firm agreed to initiate a recall,” according to an update issued by the agency. It came a day after the drug regulator said that it is “also now warning consumers and health care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination.”
The updated warning from the FDA did not provide more details about the over-the-counter ointment other than it may be contaminated with harmful bacteria.
“Using contaminated artificial tears increases the risk of eye infections that could result in blindness or death,” the FDA said in its prior update. “Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately.”
The recall and fresh warning issued this week came after the FDA on Feb. 2 said consumers and retailers should not buy EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears as the agency cited a possible bacterial contamination. EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears, and Delsam Pharma’s Artificial Eye Ointment are all manufactured by Global Pharma Healthcare, which is headquartered in Tamilnadu, India.
That came in the midst of a nationwide health alert that was issued by the U.S. Centers for Disease Control and Prevention (CDC) due to an outbreak of a drug-resistant strain of the Pseudomonas aeruginosa bacteria. In a Tuesday update, the CDC said that some 58 patients had been linked to the outbreak across about a dozen or so states.
A letter issued by the CDC several weeks ago said that cases in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, and Washington have been identified. In a recent update, Illinois was added to the list.
“These specimens were collected in both outpatient and inpatient healthcare settings,” the letter from the CDC said. “Patient outcomes include permanent vision loss resulting from ocular infection, hospitalization, and death of one patient with bloodstream infection.”
In the meantime, the FDA has cited the company for multiple violations including a “lack of appropriate microbial testing” and a “lack of proper controls concerning tamper-evident packaging.” The agency has since banned the firm’s imports to the United States.
“Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately,” the FDA previously said.
The Epoch Times has contacted Global Pharma Healthcare for comment.
EzriCare, which was involved in an earlier recall, said that it has not seen testing linking its eye drops to the antibiotic-resistant bacteria. The firm said in a statement earlier this month that it will stop distributing them in the meantime.
“As of today, we are not aware of any testing that definitively links the Pseudomonas aeruginosa outbreak to EzriCare Artificial Tears. Nonetheless, we immediately took action to stop any further distribution or sale of EzriCare Artificial Tears,” EzriCare stated on its website. “To the greatest extent possible, we have been contacting customers to advise them against continued use of the product.”
The company said it obtained a CDC notice of an investigation on Jan. 20 and hasn’t received any consumer complaints linked to its products.
“To the greatest extent possible, we have been contacting customers to advise them against continued use of the product. We also immediately reached out to both CDC and FDA and indicated our willingness to cooperate with any requests they may have of us,” said EzriCare, which added that the eye drops were manufactured in India by Global Pharma Healthcare PVT Limited and imported into the United States by Aru Pharma Inc.