On Wednesday, the U.S. Food and Drug Administration announced a link between an antibiotic-resistant bacteria and an over-the-counter eye product common in the United States. The discovery prompted a recall and warning notice.
A statement by the FDA warned users that “Delsam Pharma’s Artificial Eye Ointment, eye drops, and artificial tears could be contaminated.”
The FDA announcement read: “FDA recommended that Global Pharma recall Delsam Pharma’s Artificial Eye Ointment, and the firm agreed to initiate a recall.”
The notice comes a day after the drug regulator said 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 FDA provided few details on the bacterial contamination but noted: “Using contaminated artificial tears increases the risk of eye infections that could result in blindness or death.”
The FDA previously warned: “Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately.”
On Feb. 2, the FDA warned that EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears were linked to possible bacterial contamination.
The Epoch Times noted that “EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears, and Delsam Pharma’s Artificial Eye Ointment are all manufactured by Global Pharma Healthcare headquartered in Tamilnadu, India.”
The series of warnings come as the CDC warns of an outbreak of a new drug-resistant strain of the Pseudomonas aeruginosa bacteria. The bacteria has reportedly not previously been reported in America.
On Tuesday, the CDC said the bacteria had been reported in 60 patients across 12 states.
The CDC noted in a recent update: “These specimens were collected in both outpatient and inpatient healthcare settings. Patient outcomes include permanent vision loss resulting from ocular infection, hospitalization, and death of one patient with bloodstream infection.”
The Epoch Times report also noted that the FDA “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 is now banned from importing products to the United States.
The FDA warned: “Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately.”
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