Latest news with #AvKare
CNET
16-05-2025
- Health
- CNET
How to Find Safe Eye Drops Now That 75,000 Cases Were Just Recalled
According to the Food and Drug Administration, over 75,000 cases of AvKare eye drops and artificial tears were recalled due to deviations from Current Good Manufacturing Practices (cGMP). CGMP regulations ensure the "identity, strength, quality and purity of drug products." Shipped from May 26, 2023, through April 21, 2025, AvKare states that these are the items that were recalled: NDC# 50268-043-15 Artificial Tears Ophthalmic Solution NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution NDC# 50268-126-15 Lubricant Eye Drops Solution NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution If you purchased any of these eye drops, stop using them. To get a refund for your purchase, AvKare states that you must complete the "Quantity to Return" column and customer information block on its recall form. You can then fax this to 931-292-6229 or email customerservice@ How to find safe eye drops Eye drops are used to treat many conditions, from minor irritants to chronic vision problems. Optometrists and ophthalmologists can prescribe them to help patients heal after surgeries and to prevent infections. You can buy many of them over the counter to deal with dry eyes or an allergy flare-up. With so many options available, careful research is critical to ensure you choose the best eye drops for your particular eye issues. Ingredients vary widely by the type of eye drops, and using the wrong type can cause more problems than it solves. Know the different types of eye drops Some eye drops can be purchased over the counter, while others require a prescription. The most common ones include: Lubricating drops : Also known as artificial tears, these are designed to relieve dryness and any associated redness or irritation. Common active ingredients include polyethylene glycol and propylene glycol. The nighttime version of these drops is thicker and comes in a gel or ointment. : Also known as artificial tears, these are designed to relieve dryness and any associated redness or irritation. Common active ingredients include polyethylene glycol and propylene glycol. The nighttime version of these drops is thicker and comes in a gel or ointment. Anti-allergy drops : Antihistamine drops relieve itchiness, redness and other irritation caused by reactions to allergens like pollen or pet dander. Several options are on the market, and active ingredients vary by brand. Common ingredients include ketotifen, olopatadine, carboxymethylcellulose and glycerin. : Antihistamine drops relieve itchiness, redness and other irritation caused by reactions to allergens like pollen or pet dander. Several options are on the market, and active ingredients vary by brand. Common ingredients include ketotifen, olopatadine, carboxymethylcellulose and glycerin. Anti-redness drops: These eye drops usually contain tetrahydrozoline or brimonidine to reduce the swelling of the blood vessels in your eye. They're designed to be used sparingly. These eye drops usually contain tetrahydrozoline or brimonidine to reduce the swelling of the blood vessels in your eye. They're designed to be used sparingly. Antibiotic drops : These prescription eye drops treat infections such as pink eye or corneal ulcers caused by Pseudomonas aeruginosa. Common drugs include gentamicin sulfate and ciprofloxacin. : These prescription eye drops treat infections such as pink eye or corneal ulcers caused by Pseudomonas aeruginosa. Common drugs include gentamicin sulfate and ciprofloxacin. Steroid drops: Steroid eye drops are prescribed to reduce symptoms of inflammation like swelling or redness -- for example, after eye surgery. Steroid eye drops are prescribed to reduce symptoms of inflammation like swelling or redness -- for example, after eye surgery. Drops for treating certain health conditions: Eye doctors may prescribe various other types of eye drops to treat a range of conditions, like myopia and glaucoma. Consult your eye doctor One way to avoid problems with recalled over-the-counter brands is to go to a professional, rather than picking out eye drops yourself. In fact, you should always check with your eye doctor about the right type to buy and how to use them safely. "People don't always pay attention to what they're buying or why they're buying it," said Dr. Ronald Benner, an optometrist at Southern Montana Optometric Center who has been practicing for more than 30 years. "We strongly recommend that all patients consult with their local optometrist to make sure that they're using the right drop for the right reasons."Double-check the brand before you apply the drops With so many products being recalled (even some from major brands), the easiest way to stay up-to-date on whether your particular eye product is safe is to Google the specific product name and see if it's been listed in any FDA or CDC warnings, or has been recalled. Take a minute to do this before you put it in your eyes in case anything has changed since you initially bought it. "Ophthalmic drug products potentially pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body's natural defenses," the FDA wrote in a Oct. 27 press release. This makes it especially important to avoid products that might not be completely sterile or use safe ingredients. Identify the cause of your eye concerns Because there are so many different eye issues, finding the underlying problem is essential for choosing the right treatment. Benner notes that many patients choose drops that only provide temporary relief without addressing the underlying cause. This can lead to endless reliance on drops or even make problems worse. Dry eyes, for instance, have many potential causes. They may be a result of allergies, or your time in front of a computer might be a factor. Or you might not naturally produce enough tears. Treatment for each of these causes would be quite different. "Get the actual help to solve the problem and don't just treat a symptom," said Benner. Read more: 12 Best Foods for Eye Health Consider preservative vs. preservative-free options Most medications, including eye drops, include preservatives to help keep bugs and bacteria out. As Benner notes, they're meant to protect consumers, but they may not always be the best choice. In some cases, preservatives can irritate the tissues of the eyes. "The preservative can cause the problems that the drop is supposed to help alleviate," he said. "For many people, using a preservative-free version is much healthier and much more comfortable for the eye." In his practice, Benner always guides patients who are complaining of sensitivity or had recent surgeries to use eye drops that don't contain preservatives. Often, people who use eye drops regularly will benefit from avoiding preservatives. Again, Benner stresses that your eye doctor can steer you in the right direction based on your situation. Consider allergen-free eye drops for sensitive eyes Preservatives aren't the only potential irritant in eye drops. Antibiotics, beta-blocking agents, corticosteroids, antioxidants and other ingredients have all been associated with eye irritation in some patients. Before you use any eye drops, it's a good idea to consult your eye doctor and read ingredient labels to note any potential allergens. Med-Ved/Getty Images Safety precautions for using eye drops Choosing the right eye drops is only the first step in the process. Once you have the correct product in hand, be sure you know how to put in eye drops so you don't cause any harm to your eyes. Follow the instructions on the label Each bottle contains instructions for proper application. These ensure you use the proper dose and that it spreads over the whole surface of your eye. Instructions also include guidance on how often to apply the drops and reactions that indicate you should stop. Never use eye drops without reading these instructions. Wash your hands before each use Your hands may contain dirt, bacteria or other irritants that could affect your eyes, and there's no way to avoid putting your fingers on your eyelids when applying drops. At best, this might offset the benefits of using eye drops. At worst, it might create new problems. Always wash your hands thoroughly with soap and water before applying eye drops. Avoid contamination It's also important to keep the eye drop bottle itself sterile and free from germs, as this could result in cross-contamination between your eyes or with another user. Aside from washing your hands before you apply the drops, avoid touching the dropper to your eyes or touching the tip with your hands. Always put the cap on immediately after use and store the eye drops in a clean, sterile environment. Be on the lookout for expiration dates All eye drops have an expiration date, which is printed on the bottle. They're usually good for one to two years unopened, but this period may be shorter for eye drops that don't have preservatives. Keep in mind that preservatives and other active ingredients begin to break down once you open the bottle. This makes them less effective and increases your chances of infection. Most manufacturers recommend throwing away eye drops after they've been open for 28 days. Single-application vials should be discarded immediately after use. ProfessionalStudioImages/Getty Images Tips for correct application Even with the correct, clean drops in hand, it's important to know how to put eye drops in properly to maximize their effectiveness and reduce your chances of having a reaction. Here are a few steps you can take to correctly apply most eye drops: Wash your hands. Remove the cap and place it in a clean, dry location. Tilt your head back while pulling down your lower eyelid. Squeeze the proper amount of drops into the sac created by pulling down your lower lid. Release your eyelid and close your eyes for 30 seconds to allow the solution to spread across your eye. Repeat on your other eye if needed. When in doubt, be sure to review the instructions on the bottle. Watch for potential side effects Depending on the type of product and any allergies you may have, eye drops can cause a range of side effects. Some of the most common include redness, swelling, itching or soreness. More serious side effects may include prolonged burning, discharge, or even hives, swelling, wheezing, dizziness or vomiting. These side effects could be the result of an allergic reaction, or they may be a sign of infection or a foreign body irritating your eye. As Benner notes, the only way to be sure is to contact your eye doctor. "If the eye stays red or gets redder, those people should be seen ASAP," he said. "If there's mucus, if there's sharp pain in the eye, if there's discharge out of the eye, patients should be seen right away." TimHow to store and travel with eye drops Like any other medication, eye drops must be stored properly to prevent spoilage or the development of bacteria. Be sure to follow the manufacturer's instructions for storage location and temperature to ensure your drops stay effective and safe to use. Proper storage can be especially difficult to achieve when traveling. If you know your suitcase will sit in a hot car or airplane luggage compartment, for instance, you may want to keep your eye drops with you or run them to your hotel room sooner rather than later. Always check to ensure the lid is secure and free from any risk of contamination. Too long; didn't read Like sunglasses and other eye care products, eye drops are an important tool for maintaining eye health. Whether you get them by prescription or over the counter, it's essential to consult with your eye doctor about the correct product and learn how to put eye drops in safely. Eye drops are generally safe to use, but you should always report side effects to your doctor right away -- and avoid using any products that have been recalled.
Time of India
15-05-2025
- Health
- Time of India
FDA recalls nearly 76,000 eye care products over major safety concerns: full list inside
In a shocking development, The U.S. Food and Drug Administration (FDA) has issued an urgent recall of nearly 76,000 cases of eye care products due to serious safety concerns. This in essence, affects many popular eye drops and artificial tears that were found to have manufacturing issues, potentially putting users at risk. If you use eye drops or artificial tears, it's important to check if your product is on the list. Let's find out more... The reason behind the recall The recall followed an FDA audit, that revealed significant deviations from Current Good Manufacturing Practices (cGMP) at the manufacturing facility of BRS Analytical Service, LLC. These deviations mean that the products fall short of the required safety standards. Not only that, the FDA found a lack of assurance of sterility, which means the products might be contaminated and unsafe for use in the eyes. The list also included drops for dry eyes, as the FDA found 'lack of assurance of sterility" in the products. While the exact health risks from using these products is still being studied, the FDA classified this recall as Class II. This means that using these products could cause many health issues, and although serious harm is unlikely, the risk cannot be overlooked. List of Recalled Eye Care Products The recall covers five different ophthalmic solutions distributed nationwide between May 26, 2023, and April 21, 2025. The products have expiration dates ranging from April 2025 to March 2027. Here is the list of affected items: NDC #50268-043-15 Artificial Tears Ophthalmic Solution NDC #50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% NDC #50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution NDC #50268-126-15 Lubricant Eye Drops Solution NDC #50268-678-15 Polyvinyl Alcohol Ophthalmic Solution What should users do? Stop using the product immediately Check the lot number and expiration date on your product against the recall list available on AvKare's (a medical firm that first notified the recall) website or the FDA recall notice. Once identified, return the product to AvKare for a full refund. To do this, you need to fill out a return form available on AvKare's website, and send it to receive a Return Authorization Form. Consult your eye doctor if you experience any irritation, redness, pain, or vision problems after using the recalled products. Where Were These Products Sold? The recalled products were distributed across the United States through retail outlets, pharmacies, and online stores. Exact names of stores was no disclosed. Why is sterility important in eye products Eye drops and artificial tears must be sterile because the eyes are extremely sensitive and vulnerable to infections. Contaminated eye products can cause serious eye infections, irritation, or even damage to vision, which can also be permanent and irreversible. One step to a healthier you—join Times Health+ Yoga and feel the change
Hindustan Times
14-05-2025
- Business
- Hindustan Times
Urgent FDA recall: Nearly 76k eye care products pulled over major safety concerns: Check list of affected items
The pharmaceutical consulting business BRS Analytical Services announced a countrywide recall of about 76,000 eye drop cases, as per FDA enforcement complaint. According to AvKare, a medical firm that first notified the recall, the urgent recall comes after an FDA audit discovered many cGMP discrepancies, which are alterations from the regular manufacturing method used during pharmaceutical production. The FDA also recalled the drops, which were intended to soothe dry, itchy eyes, because of a 'lack of assurance of sterility.' While the eye drops' present threat to health is unknown, potential hazards cannot be completely ruled out, according to AvKare. Customers have been advised to immediately stop use of the impacted products. NDC #50268-043-15 Artificial Tears Ophthalmic Solution NDC #50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% NDC #50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution NDC #50268-126-15 Lubricant Eye Drops Solution NDC #50268-678-15 Polyvinyl Alcohol Ophthalmic Solution With expiration dates spanning from April 2025 to March 2027, the recalled items were distributed between May 2023 and April 2025. Also Read: Walmart hit by four food recalls in two months: Which products are affected? Consumers who want a complete refund, including shipping expenses, should return recalled items to AvKare. They will receive a return slip if they fill out a form that may be found on AvKare's website. They can fax it to 931-292-6229 or email it to customerservice@ After that, an organization will email the consumer a "Return to Authorization Form" so they can return the recalled item to the specified address and receive a complete refund, including shipping charges.
CNET
14-05-2025
- Health
- CNET
Check Your Eye Drops: 75,000 Cases Were Just Recalled
The Food and Drug Administration recently announced that testing firm BRS Analytical Service recalled over 75,000 cases of AvKare eye drop solution due to Current Good Manufacturing Practice (cGMP) deviations. Per the FDA, cGMP regulations ensure the "identity, strength, quality and purity of drug products." According to AvKare, these items, shipped from May 26, 2023, through April 21, 2025, were recalled: NDC# 50268-043-15 Artificial Tears Ophthalmic Solution NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution NDC# 50268-126-15 Lubricant Eye Drops Solution NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution If you have any of these eye drops, stop using them immediately. To get a refund, AvKare states that you must complete the "Quantity to Return" column and customer information block on its recall form. You can then fax this to 931-292-6229 or email customerservice@ How to shop for safe eye drops Eye drops are used to treat many conditions, from minor irritants to chronic vision problems. Optometrists and ophthalmologists can prescribe them to help patients heal after surgeries and to prevent infections. You can buy many of them over the counter to deal with dry eyes or an allergy flare-up. With so many options available, careful research is critical to ensure you choose the best eye drops for your particular eye issues. Ingredients vary widely by the type of eye drops, and using the wrong type can cause more problems than it solves. Know the different types of eye drops Some eye drops can be purchased over the counter, while others require a prescription. The most common ones include: Lubricating drops : Also known as artificial tears, these are designed to relieve dryness and any associated redness or irritation. Common active ingredients include polyethylene glycol and propylene glycol. The nighttime version of these drops is thicker and comes in a gel or ointment. : Also known as artificial tears, these are designed to relieve dryness and any associated redness or irritation. Common active ingredients include polyethylene glycol and propylene glycol. The nighttime version of these drops is thicker and comes in a gel or ointment. Anti-allergy drops : Antihistamine drops relieve itchiness, redness and other irritation caused by reactions to allergens like pollen or pet dander. Several options are on the market, and active ingredients vary by brand. Common ingredients include ketotifen, olopatadine, carboxymethylcellulose and glycerin. : Antihistamine drops relieve itchiness, redness and other irritation caused by reactions to allergens like pollen or pet dander. Several options are on the market, and active ingredients vary by brand. Common ingredients include ketotifen, olopatadine, carboxymethylcellulose and glycerin. Anti-redness drops: These eye drops usually contain tetrahydrozoline or brimonidine to reduce the swelling of the blood vessels in your eye. They're designed to be used sparingly. These eye drops usually contain tetrahydrozoline or brimonidine to reduce the swelling of the blood vessels in your eye. They're designed to be used sparingly. Antibiotic drops : These prescription eye drops treat infections such as pink eye or corneal ulcers caused by Pseudomonas aeruginosa. Common drugs include gentamicin sulfate and ciprofloxacin. : These prescription eye drops treat infections such as pink eye or corneal ulcers caused by Pseudomonas aeruginosa. Common drugs include gentamicin sulfate and ciprofloxacin. Steroid drops: Steroid eye drops are prescribed to reduce symptoms of inflammation like swelling or redness -- for example, after eye surgery. Steroid eye drops are prescribed to reduce symptoms of inflammation like swelling or redness -- for example, after eye surgery. Drops for treating certain health conditions: Eye doctors may prescribe various other types of eye drops to treat a range of conditions, like myopia and glaucoma. Consult your eye doctor One way to avoid problems with recalled over-the-counter brands is to go to a professional, rather than picking out eye drops yourself. In fact, you should always check with your eye doctor about the right type to buy and how to use them safely. "People don't always pay attention to what they're buying or why they're buying it," said Dr. Ronald Benner, an optometrist at Southern Montana Optometric Center who has been practicing for more than 30 years. "We strongly recommend that all patients consult with their local optometrist to make sure that they're using the right drop for the right reasons."Double-check the brand before you apply the drops With so many products being recalled (even some from major brands), the easiest way to stay up-to-date on whether your particular eye product is safe is to Google the specific product name and see if it's been listed in any FDA or CDC warnings, or has been recalled. Take a minute to do this before you put it in your eyes in case anything has changed since you initially bought it. "Ophthalmic drug products potentially pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body's natural defenses," the FDA wrote in a Oct. 27 press release. This makes it especially important to avoid products that might not be completely sterile or use safe ingredients. Identify the cause of the eye concerns Because there are so many different eye issues, finding the underlying problem is essential for choosing the right treatment. Benner notes that many patients choose drops that only provide temporary relief without addressing the underlying cause. This can lead to endless reliance on drops or even make problems worse. Dry eyes, for instance, have many potential causes. They may be a result of allergies, or your time in front of a computer might be a factor. Or you might not naturally produce enough tears. Treatment for each of these causes would be quite different. "Get the actual help to solve the problem and don't just treat a symptom," said Benner. Read more: 12 Best Foods for Eye Health Consider preservative vs. preservative-free options Most medications, including eye drops, include preservatives to help keep bugs and bacteria out. As Benner notes, they're meant to protect consumers, but they may not always be the best choice. In some cases, preservatives can irritate the tissues of the eyes. "The preservative can cause the problems that the drop is supposed to help alleviate," he said. "For many people, using a preservative-free version is much healthier and much more comfortable for the eye." In his practice, Benner always guides patients who are complaining of sensitivity or had recent surgeries to use eye drops that don't contain preservatives. Often, people who use eye drops regularly will benefit from avoiding preservatives. Again, Benner stresses that your eye doctor can steer you in the right direction based on your situation. Consider allergen-free eye drops for sensitive eyes Preservatives aren't the only potential irritant in eye drops. Antibiotics, beta-blocking agents, corticosteroids, antioxidants and other ingredients have all been associated with eye irritation in some patients. Before you use any eye drops, it's a good idea to consult your eye doctor and read ingredient labels to note any potential allergens. Med-Ved/Getty Images Safety precautions for using eye drops Choosing the right eye drops is only the first step in the process. Once you have the correct product in hand, be sure you know how to put in eye drops so you don't cause any harm to your eyes. Follow the instructions on the label Each bottle contains instructions for proper application. These ensure you use the proper dose and that it spreads over the whole surface of your eye. Instructions also include guidance on how often to apply the drops and reactions that indicate you should stop. Never use eye drops without reading these instructions. Wash your hands before each use Your hands may contain dirt, bacteria or other irritants that could affect your eyes, and there's no way to avoid putting your fingers on your eyelids when applying drops. At best, this might offset the benefits of using eye drops. At worst, it might create new problems. Always wash your hands thoroughly with soap and water before applying eye drops. Avoid contamination It's also important to keep the eye drop bottle itself sterile and free from germs, as this could result in cross-contamination between your eyes or with another user. Aside from washing your hands before you apply the drops, avoid touching the dropper to your eyes or touching the tip with your hands. Always put the cap on immediately after use and store the eye drops in a clean, sterile environment. Be on the lookout for expiration dates All eye drops have an expiration date, which is printed on the bottle. They're usually good for one to two years unopened, but this period may be shorter for eye drops that don't have preservatives. Keep in mind that preservatives and other active ingredients begin to break down once you open the bottle. This makes them less effective and increases your chances of infection. Most manufacturers recommend throwing away eye drops after they've been open for 28 days. Single-application vials should be discarded immediately after use. ProfessionalStudioImages/Getty Images Tips for correct application Even with the correct, clean drops in hand, it's important to know how to put eye drops in properly to maximize their effectiveness and reduce your chances of having a reaction. Here are a few steps you can take to correctly apply most eye drops: Wash your hands. Remove the cap and place it in a clean, dry location. Tilt your head back while pulling down your lower eyelid. Squeeze the proper amount of drops into the sac created by pulling down your lower lid. Release your eyelid and close your eyes for 30 seconds to allow the solution to spread across your eye. Repeat on your other eye if needed. When in doubt, be sure to review the instructions on the bottle. Watch out for potential side effects Depending on the type of product and any allergies you may have, eye drops can cause a range of side effects. Some of the most common include redness, swelling, itching or soreness. More serious side effects may include prolonged burning, discharge, or even hives, swelling, wheezing, dizziness or vomiting. These side effects could be the result of an allergic reaction, or they may be a sign of infection or a foreign body irritating your eye. As Benner notes, the only way to be sure is to contact your eye doctor. "If the eye stays red or gets redder, those people should be seen ASAP," he said. "If there's mucus, if there's sharp pain in the eye, if there's discharge out of the eye, patients should be seen right away." TimHow to store and travel with eye drops Like any other medication, eye drops must be stored properly to prevent spoilage or the development of bacteria. Be sure to follow the manufacturer's instructions for storage location and temperature to ensure your drops stay effective and safe to use. Proper storage can be especially difficult to achieve when traveling. If you know your suitcase will sit in a hot car or airplane luggage compartment, for instance, you may want to keep your eye drops with you or run them to your hotel room sooner rather than later. Always check to ensure the lid is secure and free from any risk of contamination. Too long; didn't read Like sunglasses and other eye care products, eye drops are an important tool for maintaining eye health. Whether you get them by prescription or over the counter, it's essential to consult with your eye doctor about the correct product and learn how to put eye drops in safely. Eye drops are generally safe to use, but you should always report side effects to your doctor right away -- and avoid using any products that have been recalled.
New York Post
14-05-2025
- Business
- New York Post
Over 75K eye care products recalled across US: See list of affected items
Nearly 76,000 cases of eye drops have been recalled nationwide by BRS Analytical Services, a pharmaceutical consulting firm, according to an FDA enforcement report. The urgent recall follows an FDA audit that found several cGMP deviations, which are departures from the standard manufacturing process during pharmaceutical production, according to AvKare, a medical manufacturer that originally reported the recall. The drops, used to relieve itchy, dry eyes, were also recalled due to a 'lack of assurance of sterility,' according to the FDA. Nearly 76,000 cases of AvKare eye drops have been recalled nationwide. The current health hazard posed to users of the eye drops is unknown, but possible risks cannot be ruled out, AvKare said. Customers should immediately stop use of the impacted products. Eye products that have been recalled so far: NDC #50268-043-15 Artificial Tears Ophthalmic Solution NDC #50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% NDC #50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution NDC #50268-126-15 Lubricant Eye Drops Solution NDC #50268-678-15 Polyvinyl Alcohol Ophthalmic Solution The recalled products were shipped out May 2023 through April 2025, and have expiration dates ranging from April 2025 through March 2027. Customers can return the recalled products to AvKare for a full refund, including shipping costs. They should complete a form linked on AvKare's website and then fax or email it to the company to receive a return slip.
