The two other eye drop recalls were not linked to the bacteria outbreak. . 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 FDA Alerts below may be specifically about Refresh Plus or relate to a group or class of drugs which include Refresh Plus. Oz. How older drivers can improve their driving at night, Accutome, Focus Laboratories, Grandall Distributing, How to find the best eye drops for your symptoms. 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 drops have not been linked to illness, the company said, though it cautioned. 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. 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. He advises exercising general precaution when using artificial tears, such as avoiding contaminating them with fingers and disposing of them within the advised time frame. 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. 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. .css-lwn4i5{display:block;font-family:Neutra,Helvetica,Arial,Sans-serif;font-weight:bold;letter-spacing:-0.01rem;margin-bottom:0;margin-top:0;text-align:center;-webkit-text-decoration:none;text-decoration:none;}@media (any-hover: hover){.css-lwn4i5:hover{color:link-hover;}}@media(max-width: 48rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}@media(min-width: 40.625rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}@media(min-width: 48rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}@media(min-width: 64rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}8 Surprising Benefits of Cycling, 12 Potential Arcturus COVID Symptoms to Know, The Reason Why You Buy Things When You're Drunk, Heres the Real Reason Why You Get Toe Cramps, How Buccal Fat Removal Surgery Actually Works. Global Pharma recalled eye drops in February after they were tied to a drug-resistant bacteria strain linked to at least three deaths. What do the numbers on your eyeglass frames mean? Anyone can read what you share. The product was distributed nationwide in the United States, and by Delsam through internet retail sites. Apotex "Brimonidine Tartrate Ophthalmic Solution, 0.15%." CDC issued an alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA. There have been a total of three deaths linked back to exposure through eye drops specifically, with federal investigators indicating that they may soon learn of additional illnesses. 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. 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. 6 of the best eye drops for dry eyes - Medical News Today Two more companies have since recalled eye drops. Legal Statement. The products are manufactured and labeled exclusively for Walgreens. Consumers are advised to stop using the following brands and return them to the place of purchase. 5%, Product Size: 15 mL, OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Product Size: 15 mL, OCuSOFT Tetravisc Forte, Product Size: 0.6 mL x 12 pcs, OCuSOFT Tetravisc Forte, Product Size: 5 mL, OCuSOFT Tetravisc, Product Size: 0.6 mL x 12 pcs, OCuSOFT Tears Again Lubricant Eye Drops , Product Size: 15 mL, OCuSOFT Tears Again Lubricant Eye Drops, Product Size: 30 mL, OCuSOFT Tears Again Lubricant Eye Ointment Nighttime Relief, Product Size: 3.5 g, OCuSOFT retaine NaCl Ophthalmic Ointment , Product Size: 3.5 g, OCuSOFT retaine NaCl Ophthalmic Solution, Product Size: 15 mL, Clear Eyes Redness Relief , Product Size: 15 mL, Clear Eyes Redness Relief , Product Size: 30 mL. Last updated on Dec 27, 2022. The Food and Drug Administration posted separate recall notices for certain eyedrops distributed by Pharmedica and Apotex after the companies said they are voluntarily pulling several lots of their products from the market. See the complete list. 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. Federal health investigators are uncovering more about an outbreak of an uncommon strain of bacteria known as Pseudomonas aeruginosa, which is increasingly being traced back to eye drops. Delsam Pharmas Artificial Eye Ointment, which has not been linked directly to illness but was produced by Global Pharma Healthcare, the same manufacturer behind the Delsam Pharmas artificial tears, has also been recalled. 1-2 drops in affected eye(s . Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Bacteria in recalled eye drops linked to cases of vision loss - CNN Heres what to know. The voluntary recall has since expanded to include over-the-counter and prescription eye care products sold under the Altaire brand name and products labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc., Natural Ophthalmics, OCuSOFT, Prestige and TRP Co. Altair reports that to date it has not received any reports of adverse effects from the voluntarily recalled products, nor has Altaire found any out-of-specifications outcomes of sterility testing for the products. No other lots are being recalled. 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. 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. Eye drops recall at Walmart, CVS, Walgreens - All About Vision Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification. Oz. Customers have been advised to immediately stop using the drops. March 7, 2023 -- Two manufacturers of eyedrops have recalled products over fears about contamination and sterility. Sign up for our newsletter to get tips directly in your inbox. About 117 million Americans used eye drops and eyewash in 2020, according to Statista, a market research firm. Waking up frequently at night can harm your health. The FDA issued recall notices last week for eyedrops made . The C.D.C. Get browser notifications for breaking news, live events, and exclusive reporting. UC Davis Health experts share what you need to know. 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. 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. Altaire has also requested that the labelers each perform a subrecall. Best preservative-free eye drops: Refresh Optive Mega-3. Oz. 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. The FDA news releases issued early in July 2019 detail Altaire's voluntary recalls of eye care products made for CVS Health, Perrigo, Walgreens and Walmart. Product Description: Lubricant Eye Drops Moisturizing Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL, Product Description: Lubricant Eye Drops Moisturizing Twin PackWalgreens item #: 801477 NDC #: 0363-0185-49 Package Size: 2 x 15 mL, Product Description: Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Walgreens item #: 801482 NDC #: 0363-7500-50 Package Size: 3.5 gram, Product Description: Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL, Product Description: Lubricant Eye Ointment PF SoothingWalgreens item #: 801486 NDC #: 0363-0191-50 Package Size: 3.5 gram. Refresh Plus Safety Alerts, Recalls & Warnings - Drugs.com Updated on: March 24, 2023 / 10:49 AM It can enter eye drops through contamination with environmental agents during handling, experts say. How to Safely Use Eye Drops After the EzriCare Recall - Verywell Health "If we don't really need something, then we probably shouldn't be using it. If you think you may have an eye infection, contact your eye care provider. The drops were manufactured in Arizona. Contact an eye doctor if you need medical attention. It has . via F.D.A. The drops were manufactured in Arizona. The import alert prevents these products from entering the United States. 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. There have been no drug safety reports related to negative health outcomes due to this product, Mr. Berman said. Here's how. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. In January, testing confirmed the Florida cases were caused by the same bacteria strain as cases in California, Connecticut and Utah. Three people have died and eight patients reported vision loss, according to the agency. Eye Drops Recall 2023: List of Brands Linked to Potential Infections Sign up for the Well+Being newsletter, your source of expert advice and simple tips to help you live well every day. The products are manufactured and labeled exclusively for Wal-Mart. Look down and gently . As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. Best for severe dry eye symptoms: GenTeal Lubricant Eye Gel. Call your doctor for medical advice about side effects. The products are distributed at the retail level by CVS. Pharmaceutical firmPharmedica USA on Marchrecalled two lots of "Purely Soothing, 15% MSM Drops," also over sterility concerns. show all 21 brands Drug class: Ophthalmic lubricants and irrigations Medically reviewed by Drugs.com. 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. The products are distributed at the retail level by Wal-Mart. Altaire has also requested that Wal-Mart notify its customers. 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. What are the symptoms of eye infection to watch out for? If youve used Ezricare and Delsam Pharmas Artificial Tears, look out for symptoms including yellow, green or clear discharge from the eye; eye pain or discomfort; redness of the eye or eyelid; a sensation that there is something in your eye; increased sensitivity to light; and blurry vision, according to the CDC. refresh plus eye drops recall - Los Feliz Ledger Here's a full list of recalled eye drops and more context on why federal regulators have placed these on recall lists in the first place: We'll continue to update this story with additional recalls and current information as it becomes available. 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. Allergan recalls Refresh, FML, Blephamide eye drops This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. 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. But when medical products such as eye drops become contaminated, the concentration of bacteria or viruses, or fungi in the product can be extremely high and overwhelm local immune responses, even when people are not overtly immune compromised, he said. For any questions regarding product returns, contact GENCO at 877-674-2087 from 7 a.m. to 5 p.m. CST. Find an eyecare professional and book online in minutes! ET. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Altaire has notified Wal-Mart 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. The AP is solely responsible for all content. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. Refresh Tears: Indications, Side Effects, Warnings - Drugs.com Best preservative-free: Systane Ultra Lubricant Eye Drops. 0.15% and were sold between last April through February. A Full List of Recalled Eye Drops Linked to Potential Bacterial - Yahoo Delsam Pharmas NDC for this product is 72570-122-35, and its UPC code is 3 72570 012235 3. 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. Best for nighttime relief . The people who were sickened most commonly reported using EzriCare brand eye drops, while some patients used multiple brands. Most Facebook users can now claim settlement money. Powered and implemented by FactSet. TO DATE, ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATION RESULTS, INCLUDING IN-HOUSE AND THIRD-PARTY STERILITY TESTING, FOR THESE PRODUCTS. TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. ET. current good manufacturing practice (CGMP), www.accessdata.fda.gov/scripts/medwatch/index.cfm. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. Novack is a clinical pharmacologist with decades of experience in ophthalmic product development. "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. is used as an eye lubricant and to relieve dryness of the eyes. 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 CDC instructs those who are experiencing such symptoms and have used either of the two eyedrops to seek medical care immediately. 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. Tilt your head back, look up, and pull down the lower eyelid to make a pouch. 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. The recall affects nearly 2,900 bottles, according to the company. Why it matters: The recall notices for select lots of Purely Soothing 15% MSM Drops and Brimonidine Tartrate Ophthalmic Solution did not list any illnesses or injuries from the products but "using . The FDA has determined these issues indicate a lack of sterility assurance. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. 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. The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles. Don't use these eyedrops: List of recalled eyedrops 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. Using contaminated artificial tears increases the risk of eye infections that could result in blindness or serious illness, Novack said. Anyone who has issues with any of the recalled eye drops can file a report with the F.D.A. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. As a precautionary measure, Altaire is 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. Delsam Pharma "Artificial Eye Ointment." Eyeglass temples: How do you know if they're the right length? "Ask your eye doctor whether you really need them," Agus said. This article will be updated with more information about current recalls as it becomes available. The drops have not been linked to illness, the company said, though it cautioned that using contaminated eye products can increase risk for infections that could result in blindness. ICE Limitations. Delsam Pharma Artificial Eye Ointment. If a patient experiences eye pain, swelling, ocular discomfort or irritation after using any of the recalled products, Allergan says the patient should contact a healthcare provider. CDC: Eyedrops sold at Walmart, other stores linked to infections - NBC News Here's what you need to know about the flurry of eye drop recalls Product was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Weeks later, two other types of eye drops were recalled because they posed a different kind of contamination risk. 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. Here's what you need to know about the flurry of eye drop recalls Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Clear Eyes Once Daily, Eye Allergy . 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. 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. Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharmas Artificial Tears. NDC#: 59390-175-35 Product Size: 4 Fl. Local health officials identified several more cases in subsequent months, with patients reporting eyes inflamed with heavy yellow pus that obscured most of the pupil. Recalled eyedrops are linked to Pseudomonas aeruginosa infections - NPR Sign up for our newsletter to get tips directly in your inbox. Read on to learn which eye drops are being recalled and why. The agency first warned of the outbreak in January, and it has now infected at least 68 people in 16 states. The content on this site is for informational purposes only. Try these 6 ways to slow memory decline and lower dementia risk. by Target Corp. said that, as of March 14, the drug-resistant bacteria strain linked to the recalled EzriCare and Delsam eye drops had been found in 68 people in 16 states. 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. Refresh Plus Preservative-Free Eye Drops for Moisturizing Relief Select eye drops have been recalled over concerns the products may not be sterile, notices posted on the Food & Drug Administration website show. He also urged consumers to consider whether they really need to use eye drops. 6 mL x 30 ct, CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, CVS Health Lubricating Gel Drops for Anytime Use, CVS Health Overnight Lubricating Eye Ointment, CVS Health Extra Strength Lubricant Gel Drops, CVS Health Extra Strength Lubricant Gel Drops Twin Pack, CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack, Item#: 495301 Product Size: 0.6 mL x 30ct, Item#: 457791 Product Size: 0.6 mL x 70ct, CVS Health Preservative Free Lubricant Eye Drops Advanced Relief, CVS Health Lubricant Eye Drops Advanced Relief, CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882 Product Size: 0.6 mL x 24 ct, CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size: 0.6 mL x 60 ct, CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief, CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack, CVS Health Maximum Redness Relief Eye Drops, CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, CVS Health Lubricant Eye Ointment Sensitive Formula. The symptoms can include yellow, green or clear discharge from the eye, redness of the eye or eyelid, increased sensitivity to light and eye pain or discomfort. For drops/gels, place the dropper directly over the eye and squeeze out 1 or 2 drops as needed. Additionally, some product packaging is leaking or may otherwise be compromised. 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. 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. The drops are distributed as Brimonidine Tartrate Ophthalmic Solution. 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. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. 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. 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. Both formulas protect tears from evaporating due to incomplete blinking from screen time. Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. 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. Global Pharma Healthcare is notifying the brand owner and importer of this product, Delsam Pharma, about this recall, and is requesting that wholesalers, retailers, and customers who have the recalled product should stop any use and discard the product safely and appropriately. Altaire ships the products labeled for Walgreens only to Walgreens. A Retail Level recall is limited to product lots currently in inventory on hand at any distributor to which Altaire Pharmaceuticals, Inc. has sold these products. Its also important to check the expiration date. 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