The Food and Drug Administration recently announced recalls of several eye drop brands linked to an outbreak of drug-resistant bacteria responsible for three deaths and multiple cases of people. Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. The Food and Drug Administration recently announced recalls of several eye drop brands linked to an outbreak of drug-resistant bacteria responsible for three deaths and multiple cases of people going blind. But the flurry of recalls is leaving some regular users of the products wondering, are they safe? More than five eye drop brands have launched recalls while health officials investigate a serious bacterial outbreak linked to blindness, eye loss and three deaths. Here's how. The company recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent because at least four bottle caps developed cracks, which could affect the products sterility. The company said that using the contaminated ointment could lead to infections that cause blindness, though it has not received any reports of injuries related to the product. On March 1, Apotex recalled prescription eye drops used to reduce eye pressure in people with glaucoma or ocular hypertension. 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. In March, a woman in Florida sued Global Pharma, claiming that an infection caused by the eye drops was so severe that doctors had to surgically remove one of her eyes. REFRESH DIGITAL lubricant eye drops act fast to relieve eye dryness that may be due to digital device use. 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. But CDC officials have also indicated they are still actively investigating the source of bacterial contamination there's a possibility that more recalls may take place in the future as healthcare providers learn more about those impacted by tainted eye drops. The content on this site is for informational purposes only. At least four eyedrop products have been recalled recently. REFRESH PLUS prescription and dosage sizes information for physicians and healthcare professionals. Altaire has also requested that Walgreens notify its customers.Altaire has notified Walgreens by e-mail on July 3, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Eating like a centenarian can help you live a longer life. At the time of the recall, there were 55 reports of adverse reactions to the drops, including eye infections, permanent vision loss and one death from a bloodstream infection. 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. The company also provided a phone number and website for people to request a recall/return packet.. First Republic Bank seized by regulators, then sold to JPMorgan Chase, Reward offered as manhunt for Texas shooting suspect reaches "dead end", Louisiana's health care deserts put women, babies at risk, doctors say, Second convoy of U.S. citizens fleeing Khartoum arrives at Port Sudan, ISIS chief killed by Turkey's intelligence agency, Erdogan says, How a tall Texan became an unlikely Australian rules football star, General Mills issues Gold Medal flour recall over salmonella concerns, Investors sue Adidas over Kanye West Yeezy deal, Shaquil Barrett's 2-year-old daughter dies in drowning accident, Three deaths linked to recalled eye drops, Health officials give new warnings about contaminated eye drops. CDC warns EzriCare eyedrops may be linked to bacterial infections, 1 death. The C.D.C. The products are manufactured and labeled exclusively for Wal-Mart. The Food and Drug Administration recently announced recalls of several eye drop brands linked to an outbreak of drug-resistant bacteria responsible for three deaths and multiple cases of people. A majority of those affected reported using preservative-free EzriCare Artificial Tears before they became. NDC#: 59390-141-56 Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, NDC#: 59390-142-49 Product Size: 2 x 15 mL, Nano Tears TF Clear Emollient Lubricant Gel Drops, Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, NDC#: 59390-143-51 Product Size: 2 x 10 mL, Nano Tears XP Clear Emollient Lubricant Gel Drops, Altaire Ofloxacin 0.3% Ophthalmic Solution USP, ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF, ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF, ActivEyes Lubricant Eye Ointment Preservative Free, NDC#: 59390-189-50 Product Size: 3.5 gram. 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. Try these 6 ways to slow memory decline and lower dementia risk. David Chen, an ophthalmologist at Singapores National University Hospital, said in an email that he does not believe people should worry about other brands that have not been recalled. 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. Written by Jay Croft. Eye Drops for Dry Eye Relief | Refresh Brand - Allergan Since then, several additional eye products have been taken off shelves, though not all are related to the bacterial infection. Both formulas protect tears from evaporating due to incomplete blinking from screen time. Stop using Refresh and call your doctor if you have: severe burning, stinging, or eye irritation after using the medicine; eye pain; or vision changes. Here's what you need to know about the flurry of eye drop recalls "If we don't really need something, then we probably shouldn't be using it. The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. Two more companies have since recalled eye drops. Anyone who has issues with any of the recalled eye drops can file a report with the F.D.A. Over-the-counter medical products aren't as closely regulated as prescription drugs, noted CBS News medical contributor Dr. David Agus. A Full List of Potentially Contaminated Artificial Tears, The 5 Best Eye Drops to Help Relieve Allergies, Your Privacy Choices: Opt Out of Sale/Targeted Ads. Recalled eyedrops causing blindness: What to know about drug-resistant What are the symptoms of eye infection to watch out for? The products are distributed at the retail level by Walgreens. With officials at the Centers for Disease Control and Prevention (CDC) issuing first warnings on the uptick in bacterial infections back in January 2023, CDC agents have now identified nearly 70 patients in 16 different states that have suffered drug-resistant infections and multiple symptoms. There's no indication the latest recalls are related to those products. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. Select one or more newsletters to continue. ISSUE: Altaire Pharmaceuticals, Inc., announced that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. Best for use with . On March 3, Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. Altaire has notified Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige by e-mail on July 16, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Tilt your head back, look up, and pull down the lower eyelid to make a pouch. Altaire ships the products labeled for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige only to Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige, respectively. Eye drops can cause infections in other parts of the body because the eye connects to the nasal cavitythrough the tear ductsand germs can move from the nasal cavity into the lungs. 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. Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. has also warned people to stop using an eye ointment manufactured by Global Pharma because of possible contamination. The affected product is packaged in a white aluminum tube within a paper carton. The recall of Brimonidine Tartrate Ophthalmic Solution was initiated due to a manufacturing problem with the caps. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. Eyeglass temples: How do you know if they're the right length? The initial recall included Ezri Care Artificial Tears Lubricant Eye Drops and Desam Pharma Artificial Tears Lubricant Eye Drops. How older drivers can improve their driving at night, Accutome, Focus Laboratories, Grandall Distributing, How to find the best eye drops for your symptoms. Allergan recently issued a voluntary U.S. recall of its Refresh Lacri-Lube, Refresh P.M., FML (fluorometholone ophthalmic ointment) 0.1%, and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment) 10%/0.2% due to customer complaints of small black particles at the time of use. 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. The drops have not been linked to illness, the company said, though it cautioned. March 7, 2023 -- Two manufacturers of eyedrops have recalled products over fears about contamination and sterility. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. "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 initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharmas Artificial Tears. Refresh Plus Preservative-Free Eye Drops for Moisturizing Relief Customers have been advised to immediately stop using the drops. Health officials said the outbreak is linked to using artificial tears. February 2, 2023 -- FDA is warning consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharmas Artificial Tears due to potential bacterial contamination. Most Facebook users can now claim settlement money. According to the Associated Press, a patient in Los Angeles County, California, who had seen an ophthalmologist in the spring of 2022 developed an eye infection. Altaire takes its mission of customer safety and providing quality products very seriously. Full list of brands. Pseudomonas aeruginosa tends to cause problems in places where immune responses are blunted, Robert T. Schooley, distinguished professor of medicine in the division of infectious diseases and global public health at the University of California at San Diego, previously told The Post. Another manufacturer,Apotex, on March 1 recalled six lots of its own brand of glaucoma drops, called "Brimonidine Tartrate Ophthalmic Solution, 0.15%," which is for patients with open-angle glaucoma or ocular hypertension. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. 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. An additional four have had to have their eyeballs surgically removed to prevent further side effects or more serious symptoms. Affected customers are being instructed to verify products implicated in these recalls by checking UPC codes on the eye drop's exterior packaging, which has been detailed in FDA recall announcements. On Thursday, the maker of the eyedrops recalled them because of possible contamination. Dry eye disease is one of the most common eye diseases and can cause irritation, grittiness, redness, burning, tearing and blurred vision. As a subscriber, you have 10 gift articles to give each month. REFRESH PLUS is preservative-free which means it's great for sensitive eyes and can be used after LASIK or other eye surgeries. Dr. Barbara Tylka, an optometrist at the Mayo Clinic in Rochester, Minn., said that, in general, eye drops are safe to use and that many people need them to treat conditions such as dryness or irritation. "Patients reported over 10 different brands of artificial tears and some patients used multiple brands," the CDC indicated. Eye drops recalls 2023: Products recalled because they may not be sterile Waking up frequently at night can harm your health. Best for LASIK dryness: Refresh Plus Lubricant Eye Drops. In January, the Centers for Disease Control and Prevention and the Food and Drug Administration warned people to stop using EzriCare Artificial Tears and Delsam Pharmas Artificial Tears after the eye drops were linked to a drug-resistant strain of the bacteria Pseudomonas aeruginosa. Clear Eyes Redness Relief (Little Drug) , Product Size: 0.2 oz. Shop Plus Lubricant Eye Drops - Value Size and read reviews at Walgreens. Any questions regarding this VOLUNTARY RECALL to the RETAIL LEVEL can be directed to Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets. Altaire takes its mission of customer safety and providing quality products very seriously. Historically, it has caused infections through sepsis (in the blood) or respiratory and urinary tract infections, with upwards of 33,000 recorded cases in the same year. Dr. Starr and Dr. Tylka both emphasized that, while the recalls were worrying, eye drops are generally safe. Pharmedica warned that patients who use the contaminated eye drops can risk going blind, but the company said it has not received any reports of infection or illness related to its product. There have not been reports of illness or infection related to the product. People who have had eye drops prescribed to them for a procedure such as cataract surgery should stop using those products once the healing process is over, she said. 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. You should avoid kava and 9 other risky dietary supplements. Oz. He said that one of the bottles was from a customer or consumer complaint and the other three were found in retained samples products that the F.D.A. July 10, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at CVS Health the during the time period as indicated in the tables below. The Centers for Disease Control and Prevention has warned people to stop using two brands of eye drops that have been linked to a drug-resistant strain of bacteria. 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. As a precautionary measure, Altaire is voluntarily initiating this recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. Best for nighttime relief . The FDA has determined these issues indicate a lack of sterility assurance. 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. Millions of consumers use nonprescription, over-the-counter drops daily as a remedy for dryness, irritation and other mild eye conditions. Two More Brands of Eyedrops Recalled Over Infection Risks - US News In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. It's currently unclear how this bacteria ended up in eye drops, but it's more likely that artificial tears are being contaminated during the manufacturing process and aren't sterile when solutions are packaged and released to the public. The Phoenix-based company said consumers should immediately stop using the drops and return them to the place they were purchased. Best for digital eyestrain: Systane Gel Drops. ET. Earlier in February, two distinct eye drop products were recalled and have been directly linked to a risk of bacterial infection Artificial Tears Lubricant Eye Drops branded by EzriCare and. The notice for the EzriCare and Delsam eye drops is here, and the notice for the Global Pharma eye ointment is here. ET. online, by mail or by fax. Symptoms associated with bacterial eye infections can include a wide array of eye-related discomfort and pain, including yellow, green or clear discharge; redness of the eye or eyelid; increased light sensitivity; consistent blurry vision; as well as an unshakable inner-eye irritation that feels like an itch, according to CDC officials. This recall is being carried out to the retail level and is only for the specific lots listed above. This product is being recalled due to non-sterility. Are Systane Ultra eye drops right for you. 2 Manufacturers Recall Eyedrops Over Safety Concerns - WebMD The company hasn't received any reports of injuries related to the drops. We're recapping that information below. Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 oz. 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. In 2017, the United States saw about 2,700 deaths related to Pseudomonas aeruginosa and 32,600 cases in hospitalized patients, according to CDC estimates. Product Description: Clear Eyes Redness Relief (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. Eye Drops Recall 2023: Full List of Brands Linked to Potential The over-the-counter drops are designed to treat eye irritation. Patients who have previously used potentially unsafe products should contact their doctors and ask for a safe substitute. CVS Health Natural Tears Lubricant Eye Drops Preservative Free, Item#: 538397 Product Size: 0.6 mL x 32 ct, CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 495334 Product Size: 0.6 mL x 60 ct, Item#: 994883 Product Size: 0. Clear Eyes Redness Relief (Select Corp) , Product Size: 0.2 oz. The company did not specify how many bottles were affected or how the bottles became not sterile. The deadly bacteria linked to recalled eyedrops causing infection and blindness had never been seen in the U.S. until 2022, according to the Centers for Disease Control and Prevention. This flurry of recalls may have you second-guessing your trusted source of dry-eye relief, but there are significant differences among the recalls and plenty of steps you can take to stay safe. The FDA has determined these issues indicate a lack of sterility assurance. What Happened To Refresh Repair Eye Drops? - On Secret Hunt NDC#: 59390-175-18 Product Size: 1 Fl. TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. Sign up for our newsletter to get tips directly in your inbox. 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. Why Trust Us? The product was distributed nationwide in the United States, and by Delsam through internet retail sites. He notes that patients should pay attention to recalls like those announced by the FDA, but they dont need to stop using all eye drops, which are safe when used correctly. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. According to CDC materials, the bacteria Pseudomonas aeruginosa is naturally found in the world around us; usually in water, soil and human waste. The over-the-counter drops are designed to treat eye irritation. To use eye drops safely, Dr. Tylka said that people should use their own bottle and make sure it has not expired. He said that when he accidentally hits his eyelid or eyelashes with the bottle tip, he considers the bottle contaminated and either resterilizes it or replaces it. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. About 117 million Americans used eye drops and eyewash in 2020, according to Statista, a market research firm. Pseudomonas aeruginosa is an aggressive bacterium that is found all over the environment, including in water, soil and human waste. 24/7 coverage of breaking news and live events. NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free. Patients who suffered infections of Pseudomonas aeruginosa reported using more than 10 brands of artificial tears, but none as often as EzriCare, according to the CDC. Zee Krstic is a health editor for Good Housekeeping, where he covers health and nutrition news, decodes diet and fitness trends and reviews the best products in the wellness aisle. The Eye Center team aims to transform vision care and develop cures for blinding eye diseases, from cornea to cortex. The recall affects nearly 2,900 bottles, according to the company. 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. Teva Pharmaceuticals have set up a recall hotline at 888-838-2872 for shoppers who have additional questions. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Healthcare providers at the University of California, Davis's Eye Center published materials that suggest that this particular bacteria impacts the eye by destroying the cornea specifically. Last updated on Dec 27, 2022. The UC Davis Eye CenterThe UC Davis Eye Center provides world-class eye care, pioneers collaborative vision research, and trains the next generation of specialists and investigators to become leaders in the Sacramento region and beyond. Change in eyesight, eye pain, or very bad eye irritation. The products are manufactured and labeled exclusively for CVS Health. People who have used these artificial tears and who have symptoms of an eye infection should see a doctor immediately, the C.D.C. Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.) An Apotex spokesperson said the company has observed four bottles with cracked caps and that there have been no reports of negative health outcomes related to the product. FDA recalls 3 brands of eye drops. What patients need to know For more information about drug recalls, visit the FDA website. Most of the time, they shouldnt cause alarm. Risk Statement: Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. TO DATE, ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATION RESULTS, INCLUDING IN-HOUSE AND THIRD-PARTY STERILITY TESTING, FOR THESE PRODUCTS. Ive continued to use eyedrops every day throughout this whole thing, Dr. Starr said. In addition to the three deaths that are being traced back to tainted eye drops, CNN reports that federal officials have indicated that eight patients have developed blindness due to the outbreak. W-M item #: 563031654 NDC # 49035-882-54: Package Size: 25 count (0.6 mL fill): Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, W-M item #: 567367998 NDC #: 49035-882-52 Package Size: 7.5 mL, Equate Support Moisture Lubricant Eye Drops, W-M item #: 553503238 NDC #: 49035-145-10 Package Size:10 mL, W-M item #: 553503238 NDC #: 49035-145-10 Package Size: 10 mL(Note: Support Harmony packaging was discontinued in January 2018.).
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