Powered and implemented by FactSet. About 117 million Americans used eye drops and eyewash in 2020, according to Statista, a market research firm. The eye drops could be contaminated, according to the recall, and may be associated with the CDC's ongoing investigation into "extensively drug-resistant" infections that weren't responsive. The FDA issued recall notices last week for eyedrops made . Infections from this bacteria strain have caused at least three peoples deaths, vision loss in eight others and the surgical removal of four peoples eyeballs. Refresh Plus Generic name: Carboxymethylcellulose [ kar-boks-ee-meth-il-SEL-yoo-lose ] Brand names: Artificial Tears, Biolle Gel Tears, Biolle Tears, GenTeal, Lubricating Plus Eye Drops, . Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Turn on desktop notifications for breaking stories about interest? The best way to find out if you have eye drops that were included in the recall is to review the recall notice provided by each company. But consumers may be confused about three other recalled eye-care products that officials are referring to currently, as these products have yet to be linked to the 68 current cases of bacterial infections logged across the U.S. Oz. Recent FDA Alerts for Refresh Plus Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility Mar 3, 2023 | Audience: Consumer March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. The three recent eye-drop recalls appear to be unrelated. New mortgage rules could lead to some homebuyers paying more, Dylan Mulvaney breaks silence on Bud Light backlash in new video, First Republic clients pulled $100 billion in deposits, Death toll climbs in outbreak linked to recalled eye drops as new treatment identified. While it's unclear based on the FDA's recall announcement when these artificial tears were initially manufactured, officials did indicate that these were likely sold and distributed online. Earlier this year, there were at least two distinct recalls that were linked to potential bacterial contamination, with CDC agents indicating that EzriCare Artificial Tears were most commonly cited in the bulk of reported infections thus far. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDAs MedWatch Adverse Event Reporting program: Consumers may also report adverse reactions by contacting FDAs Consumer Complaint Coordinators. Severe eye infections may often go ignored or misdiagnosed without clinical care, and left untreated, could cause life-threatening complications, especially with drug-resistant strains of bacteria like the one being traced by CDC officials. Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness. You should avoid kava and 9 other risky dietary supplements. TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. Altaire ships the products labeled for Wal-Mart only to Wal-Mart. "Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating whether contamination may have occurred during manufacturing," per current CDC reports. 2023 CBS Interactive Inc. All Rights Reserved. REFRESH PLUS prescription and dosage sizes information for physicians and healthcare professionals. Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. To use eye drops safely, Dr. Tylka said that people should use their own bottle and make sure it has not expired. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. See the complete list. No other lots are being recalled. More often than not, this particular strain of bacteria is resistant to antibiotic treatments and can especially prove deadly for those with weakened immune systems and those who are receiving care in hospital and clinic settings. Get browser notifications for breaking news, live events, and exclusive reporting. Global Pharma recalled eye drops in February after they were tied to a drug-resistant bacteria strain linked to at least three deaths. Prior to joining GH in 2019, Zee fostered a nutrition background as an editor at Cooking Light and is continually developing his grasp of holistic health through collaboration with leading academic experts and clinical care providers. ET. / MoneyWatch. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets. To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product. July 5, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Wal-Mart during the time period as indicated in the tables below. Change in eyesight, eye pain, or very bad eye irritation. July 16, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold by Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige Brands Inc., during the time period as indicated in the tables below. As the FDA notes, "administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.". Global Pharma Healthcare on February 2recalled all lots of its EzriCare and Delsam Pharma brands of "Artificial Tears Lubricant Eye Drops," which it said could be contaminated with bacteria. 24/7 coverage of breaking news and live events. Two types of artificial tears eye drops were voluntarily recalled after 55 reports of eye infections, vision loss and even a bloodstream infection that led to one death, according to officials. Relieve. Best for LASIK dryness: Refresh Plus Lubricant Eye Drops. Best for nighttime relief . A severe eye infection can feel similar to less threatening conditions such as dry eye disease and other autoimmune or inflammatory diseases of the eyes, experts caution. Delsam Pharma "Artificial Eye Ointment." said. As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. the eye drops were linked to a drug-resistant strain, Apotex Brimonidine Tartrate notice is here, Pharmedica Purely Soothing notice is here, the F.D.A. Altaire has also requested that Wal-Mart notify its customers. Two brands of eye drops have been pulled from shelves in January and February after they were linked to a drug-resistant bacteria strain that has caused at least three deaths and serious health issues in several others. 0.15% and were sold between last April through February. Common symptoms of an eye infection include blurry vision, discharge, pain or discomfort, redness of the eyelid or eye, feeling like there is something in the eye, and increased sensitivity to light. Try these 6 ways to slow memory decline and lower dementia risk. Drug-resistant strains of the bacteria cause more than 30,000 infections annually among hospitalized patients in the U.S. and more than 2,500 deaths. March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. kava and 9 other risky dietary supplements. Global Pharma Healthcare said in a a statementthat consumers who use the contaminated eye drops could go blind. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. OZ. Apotex said that people who received its recalled eye drops, which were distributed between April 5, 2022, and Feb. 22, should contact their health care provider and pharmacy. Clear Eyes Redness Relief (Little Drug) , Product Size: 0.2 oz. Consumers are advised to stop using the following brands and return them to the place of purchase. WASHINGTON -- U.S. health officials are alerting consumers about two more recalls of eyedrops due to contamination risks that could lead to vision problems and serious injury. The company said it launched the recall after finding cracks in a handful of bottle caps. The manufacturer, Global Pharma Healthcare, has issued a nationwide recall of the product. The over-the-counter drops are designed to treat eye irritation. Clear Eyes Redness Relief (Select Corp) , Product Size: 0.2 oz. The FDA Alerts below may be specifically about Refresh Plus or relate to a group or class of drugs which include Refresh Plus. The maker of eye drops for dry eye, rewetting drops and eye ointments sold at CVS, Walgreens and Walmart cited concerns about sterility of the ophthalmic products made at its manufacturing facility, according to the Food and Drug Administration. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product. Product Description: Clear Eyes Redness Relief (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. Two companies, EzriCare and Delsam Pharma, recalled their eye drops this month after a rare, drug-resistant bacteria called Pseudomonas aeruginosa caused infections in 55 people across 12 states. Global Pharma, which makes EzriCare and Delsam Pharmas eye drops, recalled both products in February. The products are distributed at the retail level by Wal-Mart. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. Pseudomonas aeruginosa, which occurs naturally in the environment, can spread to humans who are exposed to contaminated water or soil. REFRESH PLUS is preservative-free which means it's great for sensitive eyes and can be used after LASIK or other eye surgeries. Equate Restore Tears Lubricant Eye Drops Twin Pack, W-M item #: 552374320 NDC #: 49035-189-49 Package Size: 2 x 15 mL, W-M item #: 567371432 NDC #: 49035-887-13 Package Size: 15 mL, W-M item #: 563031651 NDC #: 49035-875-50 Package Size: 3.5 gram, Equate Comfort Gel Lubricant Eye Gel Twin Pack, W-M item #: 552374319 NDC #: 49035-197-49 Package Size: 2 x 15 mL, Equate Restore PM Nighttime Lubricant Eye Ointment, W-M item #: 551282425 NDC #: 49035-191-50 Package Size: 3.5 gram, Equate Night & Day Restore Tears Lubricant Eye Pack, W-M item #: 567368000 NDC #: 49035-883-59 Package Size: 3.5g and 15mL, W-M item #: 567371433 NDC #: 49035-885-49 Package Size: 2 x 15 mL, Equate Support Advanced Lubricating Eye Drops Dose Preservative Free. Altaire Pharmaceuticals issued voluntary recalls for eye drops and ointments sold at CVS, Walgreens, Walmart and through Perrigo and others. In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. For drops/gels, place the dropper directly over the eye and squeeze out 1 or 2 drops as needed. To safely apply eye drops, she said, people should use their nondominant hand to gently tug on the lower eyelid, look up slightly, and then, with the dominant hand, put that little drop in that lower cul-de-sac in the eyelid area.. People who have used these artificial tears and who have symptoms of an eye infection should see a doctor immediately, the C.D.C. A product whose preservative may not be effective could lead to the use of a contaminated product which creates a potential risk for eye infection. Shortly after the warning, EzriCare Artificial Tears, a preservative-free, over-the-counter product that many infected patients reported using, was recalled by its manufacturer. is used as an eye lubricant and to relieve dryness of the eyes. UC Davis Health experts share what you need to know. Common side effects of Refresh may include: mild eye burning or irritation; itching or redness of your eyes; watery eyes; blurred vision; or sensitivity to light. People not experiencing symptoms do not need to test for possible infection, it says. Altaire has also requested that the labelers each perform a subrecall. The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. Patients who have previously used potentially unsafe products should contact their doctors and ask for a safe substitute. So long as people do not touch the tip of the vial to their eyes or keep it for more than a day, preservative-free drops are safe and a great option for dry eyes, Ma said. Consumers with questions regarding this recall can contact the distributor Delsam Pharma, LLC by phone at 1-866-826-1306 or by e-mail at delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST. With millions of Americans turning to eyedrops every day the vast majority of them safely news of the illness and recalls has sparked concern and confusion. Look down and gently . "There's not much testing of safety on any of these things, so when something comes out it's because there were complaints, or in this case a drug-resistant bacteria was linked to a bunch of cases," he told CBS MoneyWatch. Global Pharma Healthcare Artificial Eye Ointment, UC Davis Health leads $2M program to improve eye care for people with diabetes, UC Davis Health opens doors to new state-of-the-art eye care facility in Sacramento, Eye Center first to test microshunt in children with refractory childhood glaucoma. Heres what to know. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. The company said it initiated the recall "out of an abundance of caution" over concerns that cracks in some of the units' caps could compromise the drops' sterility and lead to infection. The drops might be contaminated and could be a source of an outbreak of drug-resistant infections that may lead to vision loss. Find an eyecare professional and book online in minutes! Apotex is recalling six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% - prescription eye drops used to treat open-angle glaucoma or ocular hypertension. TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. If you have "artificial tears" eye drops in your home, check to make sure you don't have one of these recently recalled products. Novack is a clinical pharmacologist with decades of experience in ophthalmic product development. ICE Limitations. In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. No other lots are being recalled. Over the course of the year, other states received multiple reports of drug-resistant Pseudomonas, including a report of a Washington man who died after suffering bloodstream infection linked to over-the-counter eye drops. These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile. REFRESH PLUS Lubricant Eye Drops instantly moisturizes and relieves mild symptoms of eye dryness, including burning, irritation, and discomfort. Pseudomonas aeruginosa is an aggressive bacterium that is found all over the environment, including in water, soil and human waste.

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