- The FDA has named an Indian facility as the factory producing tainted eye drops
- The agency saw workers walking around 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 eyedrop due to risk of blindness and even lethal infection.
Now, the body has added further potentially harmful products to its list of drops that will be removed from stores – taking the total to 27.
It comes weeks after the FDA warned consumers not to buy 26 eyedrops that were all store-brand products.
Consumers were urged to avoid several drops from CVS, Rite Aid, Target and Walmart, among others.
At the time, the regulators announced that the safety concerns were related to an inspection at an unnamed factory where the products are made, which found unsanitary conditions and bacteria.
All eyedrops produced at Kilitch Healthcare India Limited have been recalled due to safety concerns, after harmful bacteria was identified at the facility
Most concerningly, the bacteria identified was drug-resistant bug pseudomonas aeruginosa.
Eyedrops contaminated with this 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 has announced the specific facility in question: Kilitch Healthcare India Limited.
The additional product is Walmart’s Equate Hydration PF Lubricant Eye Drops, 10 ml.
US health regulators are warning consumers not to use 27 brands of over-the-counter eyedrops after finding numerous health violations in the factory where they were manufactured
Agency inspectors visited the site last month and found samples that showed bacterial contamination, according to a Bloomberg report.
Microbiologists were also found to be filing backdated test results to make them appear sterile.
Additionally, some workers walked around the factory barefoot.
The Indian facility was banned from sending 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, feeling like something is in the eye, increased sensitivity to light and blurry vision
And the factory is now recalling the 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 usually made in overseas factories in countries like China and India.
‘Generics often come from one or a limited number of manufacturing facilities, and then the various drug stories will stick their own label on it,’ Dr Brian Boxer Wachler, an eye surgeon in California, previously told DailyMail.com.
According to the Centers for Disease Control and Prevention (CDC), signs of an eye infection from Pseudomonas aeruginosa include discharge from the eye, eye pain or discomfort, redness of the eye or eyelid, feeling like something is in the eye, increased sensitivity to light, and blurry vision.
The FDA urged retailers still carrying the products to cease production, and consumers should stop using them.
Consumers can also return them to the affected retailers.
Eyedrops voluntarily recalled by Kilitch Healthcare India
Lubricant Eye Drops 15 ML (Single Pack)
Lubricant Eye Drops 15 ML (Twin Pack)
Lubricant Gel Drops 15 ml (Single Pack)
Lubricant Gel Drops 15 ml (Twin Pack)
Multi-Action Relief Drops 15 ml
Lubricant Gel Drops 10 ml
Lubricant Eye Drops 10 ml (Single Pack)
Lubricant Eye Drops 10 ml (Twin Pack)
MILD MODERATE LUBRICATING EYE DROPS 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
Lubricant Eye Drops 10 ml
Lubricant Eye Drops 15 ml (single pack)
Lubricant Eye Drops 15 ml (twin pack)
Dry Eye Relief 15 ml
Eye Irritation Relief 15 ml
MULTI-ACTION RELIEF DROPS 15ML
LUBRICATING GEL DROPS 10ML
LUBRICANT EYE DROPS 10ML (TWIN PACK)
LUBRICANT GEL DROPS 15 ML
LUBRICANT EYE DROPS 15ML (TWIN PACK)
High Performance Lubricant Eye Drops 15 ml (Single Pack)
High Performance Lubricant Eye Drops 15 ml (Twin Pack)
DRY EYE RELIEF 15 ML (TWIN PACK)
Velocity Pharma LLC
LUBRICANT EYE DROP 10ML (TRIPLE PACK) Lubricant Eye Drop 10 ml (triple pack)
EQUATE HYDRATION PF LUBRICANT EYE DROPS 10ML