Regulatory Negligence: FDA Unearths Serious Sterilization Failures at Eye Drops Facility Linked to Fatal Outbreak
Global Pharma Healthcare issued a recall for its Artificial Tears Lubricant Eye Drops, marketed by EzriCare and Delsam Pharma, in response to potential bacterial infection that could cause blindness or even fatality.
The producer of the eye drops, associated with a widespread and severe bacterial infection epidemic in the US, including a minimum of three fatal cases, was found to be in violation of essential contamination prevention guidelines, as revealed by a recent FDA investigation report.
An FDA audit of Global Pharma Healthcare’s Indian plant started in the second half of February, approximately two and a half weeks post the company’s product recall due to alleged contamination risk.
At the recall’s inception, there were 55 documented adverse cases, encompassing eye infections, irreversible vision impairment and at least one fatality from a bloodstream infection. As of the previous month end, a total of 68 infections had been reported across 16 states as per the US Centers for Disease Control and Prevention. The total number of fatalities stood at three, along with eight instances of vision loss and four eye surgeries.
An exhaustive 11-day probe into the Global Pharma establishment culminated in 11 significant findings by the FDA, primarily identifying a “deficient manufacturing process compromising product sterility.” This finding specifically pertained to batches produced between December 2020 and April 2022, all of which were dispatched to the US.
The product at the epicenter of this bacterial infection outbreak, EzriCare Artificial Tears, produced by Global Pharma, has been linked to infections caused by a bacteria known as Pseudomonas aeruginosa.
This rarely encountered, drug-resistant bacteria can spread silently among asymptomatic individuals, including those who have not used the eye drops, a pattern often observed in healthcare environments.
The agency explained to CNN via email on Monday that, “The bacteria can proliferate when a carrier patient exposes another or when common items are touched, or healthcare workers transmit the bacteria, which is why maintaining stringent infection control measures, such as regular hand sanitizing, is critical.”
Several instances from the ongoing outbreak were identified in carriers who displayed no clinical infection signs or symptoms, as confirmed by the CDC. These cases were identified during screenings in inpatient healthcare facilities experiencing infection clusters.
The specific bacterial strain connected to this outbreak was previously unreported in the US, and linked infections have been identified in a variety of healthcare settings, including acute care hospitals, long-term care centers, emergency units, urgent care clinics, and other outpatient facilities.
Those affected by the outbreak reported using various artificial tear brands, but EzriCare Artificial Tears was most frequently implicated.
The FDA’s probe into the Global Pharma establishment is a component of a larger compliance issue.
The FDA asserted in a Monday email, “Our utmost priority is safeguarding public health – which includes collaborating with manufacturers to swiftly pull dangerous drugs from circulation when identified.” The agency further stated, “The FDA persists in closely monitoring this situation, in conjunction with the CDC and the companies undertaking the product recall. We strongly urge the public to discontinue usage of these potentially detrimental products.”
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