REFRESH PLUS prescription and dosage sizes information for physicians and healthcare professionals. A majority of those affected reported using preservative-free EzriCare Artificial Tears before they became. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Pharmedica "Purely Soothing, 15% MSM Drops." The import alert prevents these products from entering the United States. 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. If you have "artificial tears" eye drops in your home, check to make sure you don't have one of these recently recalled products. Last week, the FDA posted a separate recall announcement from Apotex recalling six lots of prescription eyedrops used to treat a form of glaucoma. The product can be identified by the labels below. These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile. EzriCare Artificial Tears Lubricant Eye Drop. I would encourage all people out there who take eye drops to continue using them, of course making sure that theyre not using any of these that are recalled, said Dr. Christopher Starr, a clinical spokesman for the American Academy of Ophthalmology. 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. 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. He also urged consumers to consider whether they really need to use eye drops. 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. Written by Jay Croft. Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday Friday from 9 am 5 pm ET. On March 3, Pharmedica recalled two lots of Purely Soothing 15 percent MSM. Oz. is used as an eye lubricant and to relieve dryness of the eyes. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Artificial tears, like those in the recalled EzriCare drops, are the mainstay treatment for dry eye disease, according to Jeffrey H. Ma, an ophthalmologist at the UC Davis Eye Center. Purely Soothing, 15% MSM Drops were recalled due to non-sterility. Monday - Friday, 8 a.m. - 5 p.m.:hs-publicaffairs@ucdavis.edu916-734-9040, After business hours, holidays or weekends:hs-publicaffairs@ucdavis.edu916-734-2011 (ask for public information officer), 2023UC Regents. Are Systane Ultra eye drops right for you. Legal Statement. 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. Two specific eye drop products have been expressly linked to the current Pseudomonas aeruginosa outbreak. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product. On January 20, the CDC told doctors to avoid recommending the EzriCare product. Why Trust Us? 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 eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, oz, UPC 7 31034 91382 9) have eye dropper caps and white lids. Global Pharma on February 24 alsorecalledone batch of a product distributed by Delsam Pharma,"Artificial Eye Ointment," again due to possible microbial contamination. The content on this site is for informational purposes only. The product is labeled as follows (refer the Firm Press Release for a detailed product list containing affected lot numbers): RECOMMENDATION: Consumers who have the product with any of the lot numbers listed in the Firm Press Release should stop use of the product immediately and return it to the place of purchase. 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. They include EzriCare and Delsam Pharmas Artificial Tears, which have been associated with the bacterial infection. The people who were sickened most commonly reported using EzriCare brand eye drops, while some patients used multiple brands. Since then, several additional eye products have been taken off shelves, though not all are related to the bacterial infection. TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. If you think you may have an eye infection, contact your eye care provider. 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. March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. EzriCare Artificial Tears were recalled after the CDC linked them to serious infections in multiple states. The company did not specify how many bottles were affected or how the bottles became not sterile. TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. Dry eye disease is one of the most common eye diseases and can cause irritation, grittiness, redness, burning, tearing and blurred vision. Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax. Are contact lenses a good choice for kids? equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) - Distributed by Wal-Mart Stores, Inc. Lubricant EYE DROPS FOR MILD TO MODERATE DRY EYE, STERILE, 1 FL OZ (30 mL), for Mild to Moderate Dry Eye - Distributed by CVS Pharmacy, Inc. lubricant eye drops for mild to moderate dry eye, STERILE, 1 FL OZ (30 mL) - Dist. 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. July 15, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the over the counter (OTC) and prescription (Rx) drug products and lots, within expiry, it has manufactured and distributed under the Altaire label and trade dress during the time period as indicated below. 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. The FDA issued recall notices last week for eyedrops made . Anyone can read what you share. According to CDC materials, the bacteria Pseudomonas aeruginosa is naturally found in the world around us; usually in water, soil and human waste. Delsam Pharma Artificial Tears Lubricant Eye Drops. ET. Altaire takes its mission of customer safety and providing quality products very seriously. The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. Find an eyecare professional and book online in minutes! What to Know About the Recent Eye Drop Recalls, https://www.nytimes.com/article/eye-drops-recall-explained.html. 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. Best for digital eyestrain: Systane Gel Drops. Change in eyesight, eye pain, or very bad eye irritation. Preservative-free drops come in disposable single-use vials. While this specific strain of bacteria has not been linked to eye drops previously, CDC officials noted that P. aeruginosa caused upwards of 2,700 deaths in 2017 specifically. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. kava and 9 other risky dietary supplements. 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. Product Description: Clear Eyes Redness Relief (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. On March 1, Apotex recalled prescription eye drops used to reduce eye pressure in people with glaucoma or ocular hypertension. Anyone experiencing symptoms and who have used either of the two branded eye drops recently should seek immediate emergency medical care. If you're using eye drops or eye ointments, you should check your medicine cabinet, nightstand or desk drawer in the wake of voluntary recalls by Altaire Pharmaceuticals. 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. Tilt your head back, look up, and pull down the lower eyelid to make a pouch. 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. Pharmedica is recalling its Purely Soothing 15% MSM Drops meant to treat eye irritation. The affected product is packaged in a white aluminum tube within a paper carton. The drops are distributed as Brimonidine Tartrate Ophthalmic Solution. 1-2 drops in affected eye(s . 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. 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. 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. Here's how. 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. 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. People not experiencing symptoms do not need to test for possible infection, it says. Pickup & Same Day Delivery available on most store items. They tend to be gentle on the eyes and can be used more frequently throughout the day.. 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. The over-the-counter drops are designed to treat eye irritation. The bacterium is resistant to most antibiotics and is particularly dangerous in health-care settings and for people with weakened immune systems. 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. 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. FDA recalls 3 brands of eye drops. The initial recall included Ezri Care Artificial Tears Lubricant Eye Drops and Desam Pharma Artificial Tears Lubricant Eye Drops. Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Nano Tears TF Clear Emollient Lubricant Gel Drops, Product Size: 15 mL, Nano Tears XP Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, Nano Tears XP Clear Emollient Lubricant Gel Drops, Product Size: 10 mL, Altaire Ofloxacin 0.3% Ophthalmic Solution, Product Size: 5 mL, ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF, Product Size: 7.5 mL, ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF, Product Size: 7.5 mL, ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, CVS Health Natural Tears Lubricant Eye Drops Preservative Free, Product Size: 0.6 mL x 32 ct, CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Product Size: 15 mL, CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Product Size: 30 mL, CVS Health Dry Eye Relief Eye Drops, Product Size: 15 mL, CVS Health Dry Eye Relief Eye Drops, Product Size: 30 mL, CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Product Size: 0.6 mL x 60 ct, CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Product Size: 0. Additionally, some product packaging is leaking or may otherwise be compromised. 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. 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. 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. 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. 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. 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. 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. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. On March 3, Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. Pseudomonas aeruginosa is an aggressive bacterium that is found all over the environment, including in water, soil and human waste. . 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. 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, . NanoTears HA PF Multi Dose Lubricant Gel Drops, Nano Tears MO Clear Emollient Mineral Oil Lipids, Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, NDC#: 59390-144-51 Product Size: 2 x 10 mL, Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose, Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free. REFRESH PLUS Lubricant Eye Drops instantly lubricates and moisturizes the eyes, resulting in temporary relief for mild symptoms of eye dryness. 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. Altaire has notified CVS by e-mail on July 10, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. The recall affects nearly 2,900 bottles, according to the company. Original strength formula is designed to act like your own natural tears. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. Patients who have previously used potentially unsafe products should contact their doctors and ask for a safe substitute. 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. Sign up for our newsletter to get tips directly in your inbox. The recall affects nearly 2,900 bottles, according to the company. has also warned people to stop using an eye ointment manufactured by Global Pharma because of possible contamination. A Retail Level recall is limited to product lots currently in inventory at the chain store. Shop Plus Lubricant Eye Drops - Value Size and read reviews at Walgreens. 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. Read on to learn more about a current list of recalled eye drops and symptoms of bacterial eye infections to consider. Pharmedica said that, as of March 3, it had not received any reports of illness or other adverse events from the use of the eye drops. 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. said. Eye drops recall at Walmart, CVS, Walgreens Altaire Pharmaceuticals issued voluntary recalls for eye drops and ointments sold at CVS, Walgreens, Walmart and through Perrigo. Best preservative-free: Systane Ultra Lubricant Eye Drops. 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. 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. 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. NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free. Delsam Pharma Artificial Eye Ointment. He has written about food and dining for Time, among other publications. In January, testing confirmed the Florida cases were caused by the same bacteria strain as cases in California, Connecticut and Utah. 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. Contact an eye doctor if you need medical attention. 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. 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. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. The products are distributed at the retail level by the labelers identified herein. All Rights Reserved | Terms & Conditions | Privacy Policy, Center for Healthcare Policy and Research, Betty Irene Moore School of Nursing Research, Clinical and Translational Science Center, Human Subjects Research - IRB Administration, Center for Professional Practice of Nursing, Center for Simulation and Education Enhancement, Graduate Medical Education Residencies and Fellowships, Research Education and Career Development, All UC Davis Health Staff Job Opportunities, School of Medicine Residency and Fellowship Programs, serious infections, vision loss and a death. Eating like a centenarian can help you live a longer life. Updated on: March 24, 2023 / 10:49 AM As of January 31, 2023, CDC identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears. 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. Health Manufacturer recalls eyedrops after possible link to bacterial infections Per the CDC's latest update, 68 patients across 16 states have been infected with Pseudomonas aeruginosa,. 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 notice for the EzriCare and Delsam eye drops is here, and the notice for the Global Pharma eye ointment is here. Pharmacology, adverse reactions, warnings and side effects. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death. The CDC instructs those who are experiencing such symptoms and have used either of the two eyedrops to seek medical care immediately.
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