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.. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. Pharmedica on Friday said it is recalling two lots of Purely Soothing 15% MSM Drops due to problems that could result in blindness." Delsam Pharma Artificial Tears Lubricant Eye Drops. As a subscriber, you have 10 gift articles to give each month. Global Pharma, which makes EzriCare and Delsam Pharmas eye drops, recalled both products in February. We comply with the HONcode standard for trustworthy health information. March 7, 2023 -- Two manufacturers of eyedrops have recalled products over fears about contamination and sterility. The companies involved in the recalls are Phoenix-based Pharmedica and Florida-based Apotex. 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. 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. Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharmas Artificial Tears. Product was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. It can impair vision or even blind someone.. 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. Product Description: Clear Eyes Redness Relief (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. 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. Change in eyesight, eye pain, or very bad eye irritation. Both formulas protect tears from evaporating due to incomplete blinking from screen time. Artificial tears can help with these symptoms, Ma explained. The eyedrop-related strain of Pseudomonas aeruginosa has not previously appeared in the United States, the CDC said. 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. REFRESH PLUS Lubricant Eye Drops instantly moisturizes and relieves mild symptoms of eye dryness, including burning, irritation, and discomfort. The recall came after the Centers for Disease Control and Prevention (CDC) began an investigation of a cluster of multistate bacterial infections it believed were associated with the tear drops. 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. 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. ActivEyes Nighttime Lub Eye Ointment Preservative Free, NDC#: 59390-184-50 Product Size: 3.5 gram, NDC#: 59390-198-50 Product Size: 3.5 gram, Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution. 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. Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. "Patients reported over 10 different brands of artificial tears and some patients used multiple brands," the CDC indicated. If it's not a real problem maybe we have a tiny bit of dryness we probably shouldn't be putting something into our eye," he said. Legal Statement. Is there a recall on Refresh eye drops? 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. 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. The manufacturer, Global Pharma Healthcare, has issued a nationwide recall of the product. FreshKote Lubricant Eye DropsNDC# 15821-101-15 Product Size: 15 mL, Grandall Colirio Ojo De Aguila Eye DropsProduct Size: 15 mL, Grandall Colirio Oftal-Mycin Redness Relief Eye DropsProduct Size: 15mL, Product Description: Grandall Oftal-Mycin Ophthalmic OintmentProduct Size: 3.5 g, Clear Eyes Redness ReliefUPC#: 6-78112-25415-6 Product Size: 15 mL, Product Description: Clear Eyes Redness ReliefUPC#: 6-78112-25419-4 Product Size: 30 mL. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. via F.D.A. Global Pharma on February 24 alsorecalledone batch of a product distributed by Delsam Pharma,"Artificial Eye Ointment," again due to possible microbial contamination. Do Not Sell or Share My Personal Information. All About Vision and AllAboutVision.com are registered trademarks of AAV Media, LLC. 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. 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. 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 Delsam Pharma, manufactured by Global Pharma Healthcare. Reboot. The products are manufactured and labeled exclusively for Wal-Mart. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including Sterility testing, for the products. Sign up for our newsletter to get tips directly in your inbox. The FDA has determined these issues indicate a lack of sterility assurance. Pseudomonas aeruginosa is an aggressive bacterium that is found all over the environment, including in water, soil and human waste. If you have "artificial tears" eye drops in your home, check to make sure you don't have one of these recently recalled products. All About Vision does not provide medical advice, diagnosis or treatment. Clear Eyes Redness Relief (Little Drug) , Product Size: 0.2 oz. Read on to learn which eye drops are being recalled and why. The products are distributed at the retail level by Walgreens. The products are manufactured and labeled exclusively for Walgreens. 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. Oz. If you think you may have an eye infection, contact your eye care provider. Purely Soothing, 15% MSM Drops were recalled due to non-sterility. 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. Best preservative-free: Systane Ultra Lubricant Eye Drops. ET. The recall of Brimonidine Tartrate Ophthalmic Solution was initiated due to a manufacturing problem with the caps. Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.) About 117 million Americans used eye drops and eyewash in 2020, according to Statista, a market research firm. 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. Other steps to prevent eye infections include making sure to wash your hands before touching your eyes or eye drops. 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. 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. 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. 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. The Apotex Brimonidine Tartrate notice is here and the Pharmedica Purely Soothing notice is here. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. REFRESH PLUS is preservative-free which means it's great for sensitive eyes and can be used after LASIK or other eye surgeries. The CDC and FDA urge patients to immediately stop using the recalled eye drops even if they haven't experienced an adverse reaction. Weeks later, two other types of eye drops were recalled because they posed a different kind of contamination risk. Over-the-counter medical products aren't as closely regulated as prescription drugs, noted CBS News medical contributor Dr. David Agus. No infections have been associated with this over-the-counter product. 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. Additional eye drop recalls are making headlines this month, but it's important to note that they are not expressly related to bacterial infections being linked to Pseudomonas aeruginosa. Most Facebook users can now claim settlement money. 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. ActivEyes Nighttime Lub Eye Ointment Preservative Free, Product Size: 3.5 g, Altaire Altacaine Solution, Product Size: 15 mL, ActivEyes Altachlore Ointment, Product Size: 3.5 gram, ActivEyes Altachlore Solution, Product Size: 15 mL, ActivEyes Altalube Ointment, Product Size: 3.5 gram, Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Product Size: 2.5 mL, Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Product Size: 5 mL, Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Product Size: 10 mL, Altaire Diclofenac Sodium Solution 1%, Product Size: 2.5 mL, Altaire Diclofenac Sodium Solution 1%, Product Size: 5 mL, Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution, Product Size: 5 mL, NanoTears HA PF Multi Dose Lubricant Gel Drops, Product Size: 10 mL, Nano Tears MO Clear Emollient Mineral Oil Lipids, Product Size: 10 mL, Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Product Size: 10 mL, Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack: 2 x 10 mL, Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose, Product Size: 7.5 mL. 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. 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. Waking up frequently at night can harm your health. FDA also placed Global Pharma Healthcare Private Limited on import alert for providing an inadequate response to a records request and for not complying with CGMP requirements. Why Trust Us? July 3, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Walgreens during the time period as indicated in the tables below. As of March 14, the CDC had identified 68 patients across 16 states who had been infected infected by Pseudomonas aeruginosa. The Phoenix-based company said consumers should immediately stop using the drops and return them to the place they were purchased. The company did not specify how many bottles were affected or how the bottles became not sterile. Apotex "Brimonidine Tartrate Ophthalmic Solution, 0.15%." 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. Are contact lenses a good choice for kids? 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. Pseudomonas aeruginosa can spread from one person to another through contaminated hands, equipment or surfaces, according to the CDC. 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. Health officials said the outbreak is linked to using artificial tears. March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This recall is being carried out to the retail level and is only for the specific lots listed above. Ive continued to use eyedrops every day throughout this whole thing, Dr. Starr said. Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday through Friday from 8:30 a.m. to 5:00 p.m. 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. 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. Millions of consumers use nonprescription, over-the-counter drops daily as a remedy for dryness, irritation and other mild eye conditions. Best for severe dry eye symptoms: GenTeal Lubricant Eye Gel. What are the symptoms of eye infection to watch out for? Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. 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. 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. Powered and implemented by FactSet. 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. 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. The C.D.C. 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. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Turn on desktop notifications for breaking stories about interest? The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. ET. You should avoid kava and 9 other risky dietary supplements. 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. Pharmaceutical firmPharmedica USA on Marchrecalled two lots of "Purely Soothing, 15% MSM Drops," also over sterility concerns. According to CDC materials, the bacteria Pseudomonas aeruginosa is naturally found in the world around us; usually in water, soil and human waste. 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. 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 distributed at the retail level by Wal-Mart. Market data provided by ICE Data Services. 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. 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. Best for LASIK dryness: Refresh Plus Lubricant Eye Drops. Find an eyecare professional and book online in minutes! Uses Before taking Warnings UC Davis Health experts share what you need to know. 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. For more information about drug recalls, visit the FDA website. We're recapping that information below. 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. Risk Statement: Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. Here are three ways to improve sleep. 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. 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. 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. Using contaminated artificial tears increases the risk of eye infections that could result in blindness or serious illness, Novack said. Amazon Marketplace, Etc.). Best for digital eyestrain: Systane Gel Drops. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. The FDA has determined these issues indicate a lack of sterility assurance. REFRESH PLUS Lubricant Eye Drops instantly lubricates and moisturizes the eyes, resulting in temporary relief for mild symptoms of eye dryness. Altaire ships the products labeled for CVS only to CVS. Clear Eyes Redness Relief (Select Corp) , Product Size: 0.2 oz. 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. On March 1, Apotex recalled prescription eye drops used to reduce eye pressure in people with glaucoma or ocular hypertension. 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. Pickup & Same Day Delivery available on most store items. He has written about food and dining for Time, among other publications. 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. Delsam Pharma "Artificial Eye Ointment." First published on March 8, 2023 / 5:32 PM. Altaire has also requested that Wal-Mart notify its customers. Dr. Starr, an associate professor of ophthalmology at Weill Cornell Medicine, said that one thing some patients do wrong is press the bottle tip into the inner corner of the eye, which can contaminate the drops and scratch the surface of the eye. Two other products Pharmedica USAs Purely Soothing, 15% MSM Drops and Apotexs Brimonidine Tartrate Ophthalmic Solution, 0.15% were also pulled by their makers, though they are not related to the outbreak. Pharmacology, adverse reactions, warnings and side effects. The drops might be contaminated and could be a source of an outbreak of drug-resistant infections that may lead to vision loss. ET. Please enter valid email address to continue. The drops have not been linked to illness, the company said, though it cautioned. 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. The bacteria can trigger debilitating eye infections that may cause permanent blindness, or even surgical eye removal altogether, which has been the case for at least .css-1me6ynq{-webkit-text-decoration:underline;text-decoration:underline;text-decoration-thickness:0.0625rem;text-decoration-color:#125C68;text-underline-offset:0.25rem;color:#125C68;-webkit-transition:all 0.3s ease-in-out;transition:all 0.3s ease-in-out;}.css-1me6ynq:hover{color:#595959;text-decoration-color:#595959;}one woman in Florida recently.