- The FDA has named an Indian facility as the factory producing contaminated eye drops.
- The agency saw workers walking barefoot and tampering with results.
- READ MORE: EXCLUSIVE Why you should NEVER buy generic eye drops
The Food and Drug Administration (FDA) has recalled another type of eye drops due to the risk of blindness and even fatal infection.
Now, the agency has added more potentially harmful products to its list of drops that will be removed from stores, bringing the total to 27.
It comes weeks after the FDA warned consumers not to buy 26 eye drops that were all brand-name products.
Consumers were urged to avoid several drops from CVS, Rite Aid, Target and Walmart, among others.
At the time, regulators announced that the safety issues were related to an inspection at an unnamed factory where the products are made, which found unsanitary conditions and bacteria.
All eye drops produced at Kilitch Healthcare India Limited have been recalled due to safety concerns, after harmful bacteria were identified at the facility.
Most worryingly, the bacteria identified was drug-resistant pseudomonas aeruginosa.
Eye drops contaminated with it can cause infections in the user that, in severe cases, can cause blindness and even death.
Now, the FDA has added one more product to its list and announced the specific facility in question: Kilitch Healthcare India Limited.
The bonus product is Walmart Equate Hydration PF Lubricating Eye Drops, 10ml.
U.S. health regulators are warning consumers not to use 27 brands of over-the-counter eye drops after finding numerous health violations at the factory where they were manufactured.
Agency inspectors visited the site last month and found samples showing bacterial contamination, according to a Bloomberg report.
Microbiologists were also found to be backdating test results to make them appear sterile.
Additionally, some workers walked around the factory barefoot.
The Indian facility was banned in sending the shipment of more eye drops to the US at the end of last month, according to Bloomberg.
Signs of an eye infection include discharge from the eye, pain or discomfort in the area, redness of the eye or eyelid, a feeling that something is in the eye, increased sensitivity to light, and blurred vision.
And the factory is now recalling eye drops with expiration dates ranging from November 2023 to September 2025, citing “safety concerns.”
All of the recalled products were generic, two-thirds of which are typically made in foreign factories in countries such as China and India.
“Generics often come from one or a limited number of manufacturing facilities, and then the various drug stories will slap their own label on them,” Dr. Brian Boxer Wachler, a California eye surgeon, previously told DailyMail.com.
According to the Centers for Disease Control and Prevention (CDC), signs of a Pseudomonas aeruginosa eye infection include eye discharge, eye pain or discomfort, redness of the eye or eyelid, feeling like something is in the eye, increased sensitivity to clear and blurred vision.
The FDA urged retailers still carrying the products to stop producing them and consumers to stop using them.
Consumers can also return them to affected retailers.
Kilitch Healthcare India voluntarily recalls eye drops
Lubricating Eye Drops 15 ML (Individual Package)
Lubricating Eye Drops 15 ML (Double Pack)
Lubricating gel drops 15 ml (individual package)
Lubricating gel drops 15 ml (double pack)
Multiaction Relief Drops 15 ml
Lubricating Gel Drops 10 ml
Lubricating Eye Drops 10 ml (Individual Package)
Lubricating Eye Drops 10 ml (Double Pack)
GENTLE MODERATE LUBRICANT EYEWEAR 15ML
Rugby, sold at Cardinal Health
Lubricating Tears Eye Drops 15 ml
Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
Leader, sold at Cardinal Health
Dry eye relief 10 ml
Lubricating Eye Drops 10 ml
Lubricating Eye Drops 15 ml (individual package)
Lubricating Eye Drops 15 ml (double pack)
Dry eye relief 15 ml
Eye irritation relief 15 ml
ritual of help
MULTI-ACTION RELIEF DROPS 15ML
LUBRICANT GEL DROPS 10ML
LUBRICANT EYE DROPS 10ML (Double PACK)
LUBRICANT GEL DROPS 15 ML
LUBRICANT EYE DROPS 15ML (Double PACK)
High Performance Lubricating Eye Drops 15ml (Single Pack)
High Performance Lubricating Eye Drops 15ml (Double Pack)
RELIEF FOR DRY EYES 15 ML (Double PACK)
Velocity Pharma LLC
LUBRICATING EYE DROPS 10ML (TRIPLE PACK) Lubricating eye drops 10 ml (triple pack)
EQUATE HYDRATION PF LUBRICANT EYEWEAR 10ML