More eyedrops recalled as FDA warns of infection possibility after ‘unsanitary conditions’ discovered

A voluntary recall issued for eyedrops marks the third such instance in recent weeks after “unsanitary conditions” were discovered at a manufacturing facility.

This week, Kilitch Healthcare India Limited released a statement naming 27 different eyedrops to the Food and Drug Administration’s (FDA) recall list over concerns of potential bacterial contamination. Wednesday, their statement was added to the government website detailing the list of products posing a risk of eye infections and vision loss.

“For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the statement from the manufacturer detailed. “To date, Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.”

With expiration dates spanning from Nov. 2023 through Sept. 2025, the statement specified, “These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions.”

According to the report from the FDA, among the non-sterile practices observed during their investigation, “Review of the CCTV footage from October 3 and 4th, 2023, showed personnel working…where materials are passed in to the Grade B filling area. Operators did not wear the specified gowning, gloves, and were working barefoot as they transferred materials into the Grade B area for filling line…”

“The deputy manager of production confirmed that this is their standard practice,” the report stated.

The latest recall followed earlier notices from the FDA concerning Cardinal Health Inc. and their subsidiary Harvard Drug Group LLC as the administration had warned users in late October regarding products under a list of labels and retailers that included: CVS, Equate, Leader, Rite Aid, Rugby, Target and their brand Up, Velocity Pharma and Walmart.

The FDA added, “Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled eye drops and may return any of the above listed products to the place of purchase.”

The latest recalls followed a multi-state outbreak reported in March where an “extensively-drug resistant” strain of Pseudomonas aeruginosa had initially left three people dead and four having their eyeballs removed from exposure to the rare bacteria.

“At this time CDC (Centers for Disease Control and Prevention) and FDA recommend clinicians and patients stop using EzriCare or Delsam Pharma’s Artificial Tears products pending additional guidance from CDC and FDA,” the CDC said in March after indicating the strain “had never been reported in the United States prior to the outbreak.”

As of yet, the bacteria spurring the most recent recall was not disclosed by the FDA and the CDC informed product users to pay attention to symptoms of eye infection that included: pain in and around the eyes, irritation or redness, sudden blurry vision, watery eyes, light sensitivity and/or discharge.

The FDA encourages anyone who experienced an adverse event to report online, by mail, or by fax to their MedWatch Adverse Event Reporting program.


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