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W Leggett
Eye Drop Recall Expands: 27 Products Yanked From Shelves
Kilitch Healthcare India is recalling eye drops sold at CVS, Walmart, Target and Rite-Aid after investigators found unsanitary conditions.
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Daniel Hampton,
Patch Staff
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Posted Thu, Nov 16, 2023 at 11:13 am ET
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Updated Thu, Nov 16, 2023 at 11:19 am ET
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Kilitch Healthcare India is recalling eye drops sold at CVS, Walmart, Target and Rite-Aid after investigators found unsanitary conditions.
Kilitch Healthcare India is recalling eye drops sold at CVS, Walmart, Target and Rite-Aid after investigators found unsanitary conditions. (Shutterstock)
MUMBAI, INDIA — Twenty-seven variants of eye drops sold at major retailers such as Walmart, CVS, Rite-Aid and Target are being voluntarily recalled after FDA investigators found unsanitary conditions — including reportedly barefoot workers and bogus tests meant to make the products appear safe.
As Patch previously reported in October, federal regulators warned Americans not to use 26 over-the-counter, store-brand eye drop products that they said could lead to eye infections — and partial vision loss or blindness. At the time, regulators did not name the manufacturer.
"Patients who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately," a recall notice on the FDA's website said.
The initial list of recalled products published Oct. 27 were marketed under the brands CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up and Velocity Pharma.
CVS, Rite Aid and Target removed the products from their store shelves and websites.
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On Oct. 30, the FDA updated its recall list to include Equate Hydration PF Lubricant Eye Drop 10 mL sold by Walmart online and in stores. Walmart also removed the product from its shelves, according to the FDA.
Less than a week later, Cardinal Health voluntarily recalled several Leader brand products, including one eye drop product that wasn't on the FDA's initial list of five. Harvard Drug Group also voluntary recalled all lots of two Rugby Laboratories brand eye drops.
On Nov. 10, Bloomberg reported that Kilitch Healthcare India made the eyedrops in a factory in India that was deemed by investigators as unsanitary. Some people were working barefoot in the factory, and others faked test results that made products appear safe, Bloomberg reported. Some samples showed bacteria contamination in filling areas where the products are bottled, according to Bloomberg.
On Wednesday, Kilitch Healthcare India voluntarily recalled 27 products, many of which were included in the initial recall.
"For those patients who use these products, there is a potential risk of eye infections or related harm," the FDA said.
The eye drops are supposed to be sterile, regulators said, and ophthalmic drugs pose a greater risk of harm to people because the drugs are directly applied to the eyes, bypassing some of the body’s natural defenses.
To date, Kilitch Healthcare India has not received any reports of adverse events related to this recall, the FDA said.
These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma, the FDA said.
Consumers should stop using the recalled eye drops and may return them to the place of purchase.
Below is the full list of recalled products, according to the FDA.
Rugby
LUBRICATING TEARS EYE DROPS 15 ML
Product information: Dextran 70- 0.1% w/v, Glycerin 0.2% w/v, Hypromellose 0.3% w/v
NDC Number: 0536-1282-94
Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
Product information: Polyvinyl alcohol Eye Drops 1.4% w/v
NDC Number: 0536-1325-94
Target
High Performance Lubricant Eye Drops 15 ml (Single Pack)
Product information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
NDC Number: 11673-522-15
High Performance Lubricant Eye Drops 15 ml (Twin Pack)
Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
NDC NO: 11673-522-30
DRY EYE RELIEF 15 ML (TWIN PACK)
Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
NDC NO: 76168-800-30
Rite-Aid
MULTI-ACTION RELIEF DROPS 15ML
Product Information: Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops
NDC NO: 11822-2254-3
LUBRICATING GEL DROPS 10ML
Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
NDC NO: 11822-4540-3
LUBRICANT EYE DROPS 10ML (TWIN PACK)
Product Information: Propylene glycol Eye Drops 0.6% w/v
NDC NO: 11822-4811-3
LUBRICANT GEL DROPS 15 ML
Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
NDC NO: 11822-9706-5
LUBRICANT EYE DROPS 15ML (TWIN PACK)
Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
NDC NO: 11822-9706-5
Leader
Eye Irritation Relief 15 ml
Product Information: Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops
NDC NO: 70000-0087-1
Dry Eye Relief 10 ml
Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
NDC NO: 70000-0088-1
Dry Eye Relief 15 ml
Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
NDC NO: 70000-0089-1
Lubricant Eye Drops 15 ML (Single Pack)
Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
NDC NO: 70000-0090-1
Lubricant Eye Drops 15 ML (Twin Pack)
Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
NDC NO: 70000-0090-2
Lubricant Eye Drops 10 ml
Product Information: Propylene glycol Eye Drops 0.6% w/v
NDC NO: 70000-0587-1
Velocity
Product Information:
NDC NO:
CVS
Lubricant Eye Drops 15 ML (Single Pack)
Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
NDC NO: 76168-702-15
Lubricant Eye Drops 15 ML (Twin Pack)
Product Information: Carboxymethylcellulose Sodium Eye Drops 0.5% W/V
NDC NO: 76168-702-30
Lubricant Gel Drops 15 ml (Single Pack)
Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
NDC NO: 76168-704-15
Lubricant Gel Drops 15 ml (Twin Pack)
Product Information: Carboxymethylcellulose Sodium Eye Drops 1.0% W/V
NDC NO: 76168-704-30
Multi Action Relief Drops 15 ml
Product Information: Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops
NDC NO: 76168-706-15
MILD MODERATE LUBRICATING EYE DROPS 15ML
Product Information: Polyethylene glycol 400 0.4% w/v
NDC NO: 76168-711-15
Lubricant Gel Drops 10 ml
Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
NDC NO: 76168-712-10
Lubricant Eye Drops 10 ml (Single Pack)
Product Information: Propylene glycol Eye Drops 0.6% w/v
NDC NO: 76168-714-10
Lubricant Eye Drops 10 ml (Twin Pack)Product Information: Propylene glycol Eye Drops 0.6% w/v
NDC NO: 76168-714-20
Walmart
EQUATE HYDRATION PF LUBRICANT EYE DROPS 10ML
Product Information: Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops
NDC NO: 79903-168-01
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