Latest news with #BRSAnalyticalService
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.
Forbes
14-05-2025
- Health
- Forbes
Over 75,000 Cases Of Artificial Tears, Eye Care Products Recalled
BRS Analytical Service, a pharmaceutical testing lab, is voluntarily recalling over 75,000 cases of ... More eye products, including various types of artificial tears, according to a U.S. Food and Drug Administration enforcement report. (Photo: Getty) You may want to shed some tears for this recall. Some artificial tears that it. BRS Analytical Service, a pharmaceutical testing lab, is voluntarily recalling over 75,000 cases of eye care products, including various types of artificial tears, according to a U.S. Food and Drug Administration enforcement report. This recall was also announced by AvKare, which distributed these products. This recall affects lots of eye care products. Namely, over 10 lots of five different products: So, if you recognize any of the above products, check their lot numbers and expiry dates. Don't just say, 'I'm going to put this in my eye anyway.' If your product is affected by the recall, return it for a refund or discard it immediately. And discard it doesn't mean discard it into your roommate's eyes, no matter what you think about your roommate. BRS Analytical Service initiated the recall after an FDA audit of the company found a number of deviations from Current Good Manufacturing Practice or cGMP. In this case, cGMP refers to the different things that pharmaceutical manufacturers should do to help ensure that their products have the right amount of purity, quality and safety. This includes procedures to make sure that the products are really, you know, what they are supposed to be. cGMP encompasses stuff ranging from the design of the products and manufacturing systems to checking the products that result. So that means things like getting the right raw materials for the products, putting in place strong quality management systems, making sure that the operations are robust and properly testing the products so that any deviations can be quickly detected before items are shipped. . The FDA did not specify what cGMP was not being followed. However, the FDA enforcement report did indicate that the recall was 'due to a lack of assurance to sterility.' In this case, or in these many cases of eye products, 'sterility' presumably doesn't refer to the eye products ability to reproduce. Instead, sterility means being free from biological contaminants. Getting stuff like bacteria, viruses, fungi or parasites into your eyes can lead to a real eye caramba situation. I've written previously in Forbes about how tainted eye drops have led to deaths and eyeballs removed You can get infections and resulting inflammation of different parts of your eye such as: Finally, you know how they say the eyes are the window to your soul. They are also windows to other parts of your body. Your eyes are highly vascularized, meaning that they have a good blood supply, because it help for the eyes to get oxygen so that you can do stuff like see. Therefore, any microbe that goes into your eyes could travel via the blood stream to other parts of your body. So if you've got any artificial tears or other eye care products, check their packages. Make sure that they aren't part of the recall. Unless you happen to be a scallop, you probably have no more than two eyes and want to protect them.
NBC News
13-05-2025
- Business
- NBC News
75,000 cases of eye care products just got recalled: Here's to know, plus what to buy instead
If you suffer from dry or itchy eyes, listen up: more than 75,000 cases of eye drop solution were voluntarily recalled nationwide by BRS Analytical Service, a pharmaceutical testing lab, according to an enforcement report from the Food and Drug Administration. AvKare, a manufacturer of medical, surgical and pharmaceutical items, originally reported the recall. Why are certain eye care products being recalled? The recall follows an FDA audit at BRS Analytical Service, which found a number of Current Good Manufacturing Practice (cGMP) deviations. The cGMP is a set of regulations enforced by the FDA to ensure that manufacturers use safe practices to produce pharmaceutical products. 'cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products,' according to the statement from AvKare. Additionally, the enforcement report says the reason for the recall is 'due to a lack of assurance to sterility.' The recalled products, also described as 'eye lubricants,' help relieve dry and irritated eyes. What products are part of the recall? The recall encompasses ophthalmic solutions shipped over a two year period from: May 26, 2023 until April 21, 2025, according to AvKare. If you have any of the below items, you should stop using them immediately: 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 you do? In addition to pausing any use of the above compromised products, you can follow the steps below and swap in one of our expert-approved alternatives. If you have any of the recalled products, or think you may have any of them, AvKare is encouraging consumers to fill out a Recall Form and email it to them. After sending in the form, the organization will then send you a Return Authorization Form, which you can use to send the products into the following address with the package marked: Ophthalmic RECALL. They will also issue full credit including shipping costs for returns. R&S Northeast LLC 8407 Austin Tracy Rd Fountain Run, KY 42133 Expert-recommended alternatives to use instead If you suffer from dry, itchy or irritated eyes, experts recommend using the following methods to help alleviate symptoms. To treat aqueous dry eye, also known as blepharitis, it's best to use a warm compress over the eyes for about 30 seconds daily, according to Dr. Yuna Rapaport, a board-certified ophthalmologist at Manhattan Eye. Additionally, 'humidity in the bedroom is also helpful for evaporative dry eye,' says Rapaport. Consider using a humidifier in your room to help alleviate symptoms. Ocusoft These cleansing eyelid pads also come recommended by Rapoport to help with dry eyes. The set includes 35 fragrance- and alcohol-free pads that help remove makeup, pollen and oils that can irritate the eyes, according to the brand. Eye Revive by Daily Practice Rapaport recommends this foaming cleanser to help hydrate and soothe eyelids. It has glycerin, a humectant that hydrates skin by pulling moisture from the air, and fruit extracts with antioxidants, like lycopene, that can help prevent skin damage from free radicals, according to the brand. Rapaport says to use the cleanser by gently scrubbing over and around the eyelids. She also recommends applying the solution to a cotton pad and washing the inner and outer corners of the eyes. A warm compress can also be a great alternative for soothing irritated eyes, according to Rapaport. This compress, which has a 4.5-star average rating from 1,745 reviews on Amazon, has 30 self-heating eye compresses to relieve dry eyes, reduce eyelid inflammation and unblock glands in the eyes, according to the brand. Since they're self-heating you don't need to put them in the microwave and risk them getting too hot. You can also use your FSA funds to purchase these. Levoit Humidifier A humidifier also helps relieve dry eyes by adding moisture to an environment, like your bedroom. This 2.5-liter option has an auto shut-off feature and is BPA free. Humidifiers are great to have around especially if you have allergies and regularly get irritated eyes or experience dryness or allergies. Meet our expert At NBC Select, we work with experts who have specialized knowledge and authority based on relevant training and/or experience. We also take steps to ensure all expert advice and recommendations are made independently and without undisclosed financial conflicts of interest. Why trust NBC Select? I'm a commerce editor at NBC Select, where I write about deals and sale events, product reviews and roundups and articles on product recalls. I reviewed a statement issued by AvKare and researched documents from the FDA as well as spoke with a board-certified ophthalmologist for this story.
Fast Company
12-05-2025
- Business
- Fast Company
Eye drop recall: Nearly 76,000 cases of eye care products are feared to be of ‘unacceptable quality'
If you're a frequent eye drop user, now's the time to check your medicine cabinet: The pharmaceutical lab BRS Analytical Service, LLC has issued a voluntary recall of five different ophthalmic solutions, including some eye drops and artificial tears, due to concerns that the products may be of 'unacceptable quality.' Here's what to know: What is the reason for the recall? According to a notice published by the distributor AvKare, the recall was initiated when a U.S. Food and Drug Administration (FDA) audit found 'manufacturing cGMP deviations' in the production of the five eye products. CGMP, or Current Good Manufacturing Practice, refers to the required manufacturing process guidelines set by the FDA for a certain item. Per the AvKare notice, 'Health Hazard to the user is unknown, cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.' Separately, an FDA enforcement report surrounding the five products notes that there was a 'lack of assurance of sterility' found during the agency's audit. BRS Analytical Service voluntarily initiated the five recalls on April 23. On May 6, the FDA classified each as a Class II, meaning it is considered a situation in which exposure to the product may cause 'reversible adverse health consequences,' or where the probability of serious health consequences is 'remote.' Which products are being recalled? The recall encompasses five products, totaling over 75,000 cases of ophthalmic solution, shipped over a two-year period: May 26, 2023, to April 21, 2025. The products include: NDC# 50268-043-15 Artificial Tears Ophthalmic Solution; recall number D-0404-2025 NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%; recall number D-0405-2025 NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution; recall number D-0406-2025 NDC# 50268-126-15 Lubricant Eye Drops Solution; recall number D-0407-2025 NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution; recall number D-0408-2025 Detailed lots numbers and specific expiration dates can be found here. Where were the products sold? According to the FDA, the items were distributed nationwide in the U.S., though specific states and stores were not listed. What should I do if I have one of the recalled products? If you have a recalled eye solution, do not use it. Instead, AvKare requests that you follow the instructions listed in its notice to alert the company that you received the recalled product, and then ship the affected items back to its headquarters.
Yahoo
12-05-2025
- Health
- Yahoo
Eye care products recalled nationwide as customers warned to stop use ‘immediately'
Nearly two million cartons of eyedrops have been recalled due to concerns about quality. BRS Analytical Service, LLC announced the urgent recall of five eye care products, healthcare distributor AvKARE shared in a recent press release. The recall comes after a Food and Drug Administration (FDA) audit identified violations of Current Good Manufacturing Practice (CGMP). CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. Although it's unclear what health risks may be posed, CGMP deviations could lead to 'unacceptable quality' of the recalled eyecare solutions, and it's 'not possible to rule out patient risks resulting from use of these products,' according to AvKARE. The five solutions that have been recalled are Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution. Eye solutions were shipped from May 26, 2023, until April 21, 2025. Consumers are being asked to fill out the 'Quantity to Return' section and the customer information block on the recall notice, which can be faxed or emailed to AvKARE. People are urged to submit the forms even if they don't have the recalled eyecare solutions anymore. Consumers should throw away these products immediately or return them to the place of purchase to get a full refund. You can find a list of all the eyecare products that were a part of this recall here. According to the FDA, the recall was also issued due to a 'lack of assurance of sterility' in these products. The recall affects more than 1.8 million cartons of eye drops. On May 6, the recall was identified as a Class II one, which is 'a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,' according to the FDA. The eyecare solutions are one of many everyday products that have been recalled in 2025. Earlier this month, popular wellness brand Optimal Carnivore issued a voluntary recall on 1,500 bottles of their Bone & Joint Restore capsules, after they were distributed nationwide through major retailers, such as Amazon. The capsules, which contain bone marrow and bones from cows, were recalled due to potential salmonella contamination. Salmonella infection is a common bacterial disease that can affect the intestinal tracts and occurs after drinking contaminated water, eating raw meat, poultry, eggs, or unpasteurized milk. In March, the FDA announced a recall of 1,068 bottles of Henkel's Tec Italy Totale Shampoo because they may contain the bacteria Klebsiella oxytoca, which can cause infections in the eyes, nose, and skin.
