The Food and Drug Administration (FDA) has issued a recall for an additional type of eyedrop, bringing the total to 27, due to the risk of blindness and lethal infection.
This action follows weeks of warnings to consumers about 26 eyedrops, including store-brand products from CVS, Rite Aid, Target, and Walmart.
FDA’s Investigation and Facility Identification:
Inspection Findings and Safety Concerns:
The FDA had initially raised safety concerns based on an inspection at an unnamed factory, revealing unsanitary conditions and bacterial contamination.
The identified bacteria, pseudomonas aeruginosa, is a drug-resistant bug that can lead to severe infections, including blindness and death.
Named Facility and Inspection Results:
The FDA has now disclosed the specific facility in question as Kilitch Healthcare India Limited.
Inspectors visited the site earlier this year and found bacterial contamination in samples.
Shockingly, microbiologists were caught filing backdated test results to falsely indicate sterility.
Additionally, some workers were observed walking around the factory barefoot.
Recalled Product and Factory Response:
Product Addition and Factory’s Recall:
Walmart’s Equate Hydration PF Lubricant Eye Drops, 10 ml, has been added to the list of recalled products.
Kilitch Healthcare India Limited, the implicated Indian facility, has been banned from sending more eye drops to the US.
The factory is now recalling the affected eye drops, citing ‘safety concerns,’ with expiration dates ranging from November 2023 to September 2025.
Generic Products and Overseas Manufacturing:
All the recalled products were generic, with a significant portion manufactured in overseas factories, including countries like China and India.
The FDA urged retailers still carrying these products to halt production, and consumers are advised to discontinue use and return them to the retailers.
Health Risks and Symptoms:
Pseudomonas aeruginosa Infection:
Infections from eyedrops contaminated with pseudomonas aeruginosa can lead to symptoms such as discharge from the eye, eye pain, redness, feeling like something is in the eye, increased sensitivity to light, and blurry vision.
The CDC highlights these signs of an eye infection caused by this drug-resistant bacteria.
FDA’s Advisory and Consumer Action:
The FDA strongly advises retailers to cease production of the recalled products, and consumers should stop using them.
Eyedrops voluntarily recalled by Kilitch Healthcare India, including various brands, should be returned to the affected retailers.
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