FDA faults company behind recalled eye drops for multiple violations
The Food and Drug Administration announced Thursday that it has moved to restrict imports of products manufactured by an Indian healthcare firm, after it urged the company to recall eye drops linked to an outbreak of "extensively drug-resistant" bacteria across the country.
Global Pharma Healthcare Private Limited produces artificial tears that are sold under the brand names EzriCare or Delsam Pharma, which are now all being recalled.
The FDA cited multiple violations of manufacturing regulations by the company, including a "lack of appropriate microbial testing" and a "lack of proper controls concerning tamper-evident packaging."
"FDA is warning consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma's Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death," the agency said in a statement Thursday.
The regulator's warning comes a day after the U.S. Centers for Disease Control and Prevention issued a health alert to doctors around the country over an unprecedented outbreak of Pseudomonas aeruginosa that had sickened at least 55 people across a dozen states.
The specific strain behind the outbreak — dubbed Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant (VIM-GES-CRPA) — is so rare that the agency has never seen it before in the U.S.
But testing of opened bottles of EzriCare eye drops from patients in two different states turned up bacteria matching the outbreak strain.
"VIM-GES-CRPA recovered from opened bottles could represent either bacterial contamination during use or during the manufacturing process. Testing of unopened bottles of EzriCare Artificial Tears is ongoing," the CDC said.
At least one person has died following a "systemic infection" resulting from the bacteria. So far, at least five of the 11 patients who have had infections directly in their eyes have lost their vision, a CDC spokesperson said.
The bacteria in the outbreak has taken hold in a range of different parts of the body for patients in the outbreak, ranging from respiratory infections to the urinary tract.
This strain is particularly tricky for doctors to treat because it has at least some resistance to a dozen different antibiotics tested by the CDC. Only one – cefiderocol – appears to work for the strain.
"Patients who have used EzriCare preservative-free artificial tears and who have signs or symptoms of an eye infection should seek medical care immediately," the agency says.
Symptoms can include pain or discomfort in the eye, as well as yellow, green or clear discharge coming out of the eye. Redness in the eye, increased sensitivity to light, and blurry vision can also be signs of an eye infection.
While patients in the outbreak had used multiple artificial tears products, the CDC said EzriCare is the only brand that was identified across all "four healthcare facility clusters" of cases.
"Eye drops were obtained through Amazon and Walmart; some patients received eye drops while inpatient or during outpatient care visits," the CDC's Martha Sharan told CBS News in a statement.
At one point last year, EzriCare's eye drops had ranked among one of the top ten selling products on Amazon for "dry eye relief."
But by January, the FDA had added its manufacturer, Global Pharma, on the agency's so-called "red list" of banned imports. The company was added to the list over "an inadequate response" to the regulator's records request and failing to comply with manufacturing requirements.
Among its violations, the FDA faulted the company for making and selling its eye drops in multiple-use bottles without preservatives, which can make it easier for bacteria to grow between uses.
In a statement, Global Pharma said it was "fully cooperating" with federal authorities to investigate the issue.
"Thus far we have not determined whether our manufacturing facility is the source of the contamination. Nevertheless, out of an abundance of caution, we are recalling the products at issue," the company said.
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