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Rachel V Thomas

Eye Drops: US FDA Recalls Over 3 Million Products Over Safety Concerns

The <span>US Food and Drug Administration</span> has recalled over three million <span>eye drops</span> in the country over safety concerns. 

The 3,111,072 products were manufactured by California-based <span>K C Pharmaceuticals</span> and were sold under names such as “Dry Eye Relief Eye Drops,” “<span>Sterile</span> Eye Drops,” and “Artificial Tears Sterile Lubricant Eye Drops,” according to the <span>FDA</span> notice. 

K C Pharmaceuticals made the voluntary recall of the eye drops in early March. 

The eight types of eye drop products were sold at major retailers, including CVS, <span>Walgreens</span>, and <span>Rite Aid</span>. They have expiration dates ranging from April to October. 

<h2>Eye Drops: Why Are These Recalled? What Did The US FDA Say </h2>

The FDA, in its Enforcement Reports, stated that the products recalled “lack of assurance of sterility.”

While so far, there are no reports of injuries associated with the eye drops, the FDA notice classified the action as a “Class II recall.” 

Class II recalls apply to products that can cause “temporary or medically reversible” health problems. 

As per the FDA, "the probability of a serious health issue is remote," over these products, and that is why the recall is categorized as a Class II, USA TODAY reported 

"Patients and consumers can continue using the medicine unless otherwise directed by the recalling company or FDA," the regulator said in a statement to the publication.

<strong>Also read: </strong><a href="https://www.healthandme.com/health-wellness/can-eye-strain-lead-to-brain-cancer-experts-explain-article-153958530" data-type="tilCustomLink">Can 'Eye Strain' Lead To Brain Cancer? Experts Explain</a> <h2></h2>

<h2>Which Eye Drops Have Been Recalled? </h2>

NBC News reported that the recalled products include: 

<ol><li>Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl oz (15 mL) bottles </li><li>EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1%, and tetrahydrozoline HCl 0.05%), 0.5 fl oz (15 mL) bottles</li><li>Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2%, and polyethylene glycol 400 1%) 0.5 fl oz (15 mL) bottles</li><li>Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 fl oz (15mL) bottles</li><li>Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl oz (15mL) bottles.</li><li><span rel="noindex">Sterile Eye Drops Redness Lubricant</span> (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles</li><li>Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles.</li><li>Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl oz (15 mL) bottles.</li></ol>

      <h2>Here’s What You Can Do Instead? </h2>

Also read: <a href="https://www.healthandme.com/health-wellness/struggling-with-dry-eyes-study-reveals-surprising-treatment-tips-to-prevent-this-disease-article-151038324" data-type="tilCustomLink">Struggling With Dry Eyes? Study Reveals Surprising Treatment- Tips To Prevent This Disease</a> 

The key to ensuring that your eyes are protected from environmental factors like the sun, dust, and dirt, especially for those who work outdoors or spend long hours on screen, is investing in good sunglasses with ultraviolet protection. 

"For those who are using computers a lot, you need to blink your eyes constantly, take breaks in between, and drink a lot of water. Dehydration is also a contributing factor to dry eye," Dr Anita Sethi, who is Principal Director and HOD Ophthalmology, Max Multi Specialty Centre at Panchsheel Park.

She also recommends using zero-number protective glasses and computer glasses that can decrease strain and dry eye.

While advising people to stay away from natural remedies like turmeric or ginger put inside the eye, Dr Sethi urged people to consume more “foods rich in vitamin E, antioxidants” to maintain eye health. 

“Colored vegetables and fruits, and even maintaining thyroid and vitamin D levels, because these also contribute to dry eye,” the ophthalmologist said.

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The US Food and Drug Administration has recalled over three million eye drops in the country over safety concerns. The 3,111,072 products were manufactured by California-based K C Pharmaceuticals and were sold under names such as “Dry Eye Relief Eye Drops,” “Sterile Eye Drops,” and “Artificial Tears Sterile Lubricant Eye Drops,” according to the FDA notice. K C Pharmaceuticals made the voluntary recall of the eye drops in early March. The eight types of eye drop products were sold at major retailers, including CVS, Walgreens, and Rite Aid. They have expiration dates ranging from April to October. Eye Drops: Why Are These Recalled? What Did The US FDA Say The FDA, in its Enforcement Reports, stated that the products recalled “lack of assurance of sterility.”While so far, there are no reports of injuries associated with the eye drops, the FDA notice classified the action as a “Class II recall.” Class II recalls apply to products that can cause “temporary or medically reversible” health problems. As per the FDA, "the probability of a serious health issue is remote," over these products, and that is why the recall is categorized as a Class II, USA TODAY reported "Patients and consumers can continue using the medicine unless otherwise directed by the recalling company or FDA," the regulator said in a statement to the publication. Also read: Can 'Eye Strain' Lead To Brain Cancer? Experts Explain Which Eye Drops Have Been Recalled? NBC News reported that the recalled products include: Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl oz (15 mL) bottles EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1%, and tetrahydrozoline HCl 0.05%), 0.5 fl oz (15 mL) bottlesDry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2%, and polyethylene glycol 400 1%) 0.5 fl oz (15 mL) bottlesUltra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 fl oz (15mL) bottlesSterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl oz (15mL) bottles.Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottlesSterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles.Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl oz (15 mL) bottles.      Here’s What You Can Do Instead? Also read: Struggling With Dry Eyes? Study Reveals Surprising Treatment- Tips To Prevent This Disease The key to ensuring that your eyes are protected from environmental factors like the sun, dust, and dirt, especially for those who work outdoors or spend long hours on screen, is investing in good sunglasses with ultraviolet protection. "For those who are using computers a lot, you need to blink your eyes constantly, take breaks in between, and drink a lot of water. Dehydration is also a contributing factor to dry eye," Dr Anita Sethi, who is Principal Director and HOD Ophthalmology, Max Multi Specialty Centre at Panchsheel Park.She also recommends using zero-number protective glasses and computer glasses that can decrease strain and dry eye.While advising people to stay away from natural remedies like turmeric or ginger put inside the eye, Dr Sethi urged people to consume more “foods rich in vitamin E, antioxidants” to maintain eye health. “Colored vegetables and fruits, and even maintaining thyroid and vitamin D levels, because these also contribute to dry eye,” the ophthalmologist said.

eye drops: us fda recalls over 3 million products over safety concerns

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