Best for use with . Amazon Marketplace, Etc.). The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. First published on March 8, 2023 / 5:32 PM. 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. BACKGROUND: Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box. Call your doctor for medical advice about side effects. TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. Apotex is recalling six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% - prescription eye drops used to treat open-angle glaucoma or ocular hypertension. Written by Jay Croft. CBS News' Alexander Tin and the Associated Press contributed to this report. What are the symptoms of eye infection to watch out for? And symptoms triggered by this particular bacterial infection may start presenting usually within 12 to 24 hours, per published research. 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. ET. 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. The three recent eye-drop recalls appear to be unrelated. 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. Patients should not use eye-care products beyond the expiration date, as they may not be stable or sterile, Ma explained. But the flurry of recalls is leaving some regular users of the products wondering, are they safe? For more information about drug recalls, visit the FDA website. 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. Most Facebook users can now claim settlement money. Artificial tears can help with these symptoms, Ma explained. Pseudomonas aeruginosa, which occurs naturally in the environment, can spread to humans who are exposed to contaminated water or soil. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. This recall is being carried out to the retail level and is only for the specific lots listed above. A majority of those affected reported using preservative-free EzriCare Artificial Tears before they became. 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. 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. has also warned people to stop using an eye ointment manufactured by Global Pharma because of possible contamination. Anyone who has issues with any of the recalled eye drops can file a report with the F.D.A. 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. The Eye Center team aims to transform vision care and develop cures for blinding eye diseases, from cornea to cortex. 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. Customers have been advised to immediately stop using the drops. The products are manufactured and labeled exclusively for Walgreens. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. The company also provided a phone number and website for people to request a recall/return packet.. Global Pharma recalled eye drops in February after they were tied to a drug-resistant bacteria strain linked to at least three deaths. Drug-resistant strains of the bacteria cause more than 30,000 infections annually among hospitalized patients in the U.S. and more than 2,500 deaths. 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. current good manufacturing practice (CGMP), www.accessdata.fda.gov/scripts/medwatch/index.cfm. Anyone experiencing symptoms and who have used either of the two branded eye drops recently should seek immediate emergency medical care. The Apotex Brimonidine Tartrate notice is here and the Pharmedica Purely Soothing notice is here. 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. If you are using any of these specific products, stop, said Gary D. Novack, a professor at UC Davis Health. 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. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification. Also in March, Apotex Corp. recalled Brimonidine Tartrate Ophthalmic Solution, 0.15% out of an abundance of caution due to cracks in some of the bottles caps, which could affect the products sterility, the company said. 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. It can enter eye drops through contamination with environmental agents during handling, experts say. 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. One person died and at least five others had permanent vision loss. There's no indication the latest recalls are related to those products. 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. All About Vision and AllAboutVision.com are registered trademarks of AAV Media, LLC. 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. 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. What to know about the eyedrop recall linked to deaths and vision loss, GM recalls 40,000 Silverado pickups over fire risk, More than 570,000 Hyundai and Kia vehicles recalled over fire risk, Turn winter carrots and oranges into a fresh spring salad, Pasta primavera is primed for its comeback tour, This clam toast is a shortcut to the classic New Haven pizza. Infections from this bacteria strain have caused at least three peoples deaths, vision loss in eight others and the surgical removal of four peoples eyeballs. FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and state and local health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. Eyeglass temples: How do you know if they're the right length? 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. 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. 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. The company said it initiated the recall "out of an abundance of caution" over concerns that cracks in some of the units' caps could compromise the drops' sterility and lead to infection. The UC Davis Eye Center has not seen any cases linked to the EzriCare drops, but infections have been reported in 12 states, including California. 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. As a subscriber, you have 10 gift articles to give each month. Each notice has details on which batch of each product was affected. Do Not Sell or Share My Personal Information. Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharmas Artificial Tears. We may earn commission from links on this page, but we only recommend products we back. 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. Sign up for the Well+Being newsletter, your source of expert advice and simple tips to help you live well every day. 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. / MoneyWatch. If you have "artificial tears" eye drops in your home, check to make sure you don't have one of these recently recalled products. The foregoing products are manufactured and labeled by Altaire Pharmaceuticals, Inc. Altaire has notified all distributors by e-mail on July 15, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. The notice for the EzriCare and Delsam eye drops is here, and the notice for the Global Pharma eye ointment is here. March 7, 2023 -- Two manufacturers of eyedrops have recalled products over fears about contamination and sterility. Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday Friday from 9 am 5 pm ET. The best way to find out if you have eye drops that were included in the recall is to review the recall notice provided by each company. 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. 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. They include EzriCare and Delsam Pharmas Artificial Tears, which have been associated with the bacterial infection. 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. Relieve. He also urged consumers to consider whether they really need to use eye drops. 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. No other lots are being recalled. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. 2023 CBS Interactive Inc. All Rights Reserved. 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. For drops/gels, place the dropper directly over the eye and squeeze out 1 or 2 drops as needed. 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. 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. Best for LASIK dryness: Refresh Plus Lubricant Eye Drops. 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. 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. As of March 14, the CDC had identified 68 patients across 16 states who had been infected infected by Pseudomonas aeruginosa. requires a company to keep back in case issues like these arise. About 117 million Americans used eye drops and eyewash in 2020, according to Statista, a market research firm. It can impair vision or even blind someone.. Millions of consumers use nonprescription, over-the-counter drops daily as a remedy for dryness, irritation and other mild eye conditions. FDA recalls 3 brands of eye drops. Equate Restore Tears Lubricant Eye Drops Twin Pack, W-M item #: 552374320 NDC #: 49035-189-49 Package Size: 2 x 15 mL, W-M item #: 567371432 NDC #: 49035-887-13 Package Size: 15 mL, W-M item #: 563031651 NDC #: 49035-875-50 Package Size: 3.5 gram, Equate Comfort Gel Lubricant Eye Gel Twin Pack, W-M item #: 552374319 NDC #: 49035-197-49 Package Size: 2 x 15 mL, Equate Restore PM Nighttime Lubricant Eye Ointment, W-M item #: 551282425 NDC #: 49035-191-50 Package Size: 3.5 gram, Equate Night & Day Restore Tears Lubricant Eye Pack, W-M item #: 567368000 NDC #: 49035-883-59 Package Size: 3.5g and 15mL, W-M item #: 567371433 NDC #: 49035-885-49 Package Size: 2 x 15 mL, Equate Support Advanced Lubricating Eye Drops Dose Preservative Free. Get browser notifications for breaking news, live events, and exclusive reporting. TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. The CDC instructs those who are experiencing such symptoms and have used either of the two eyedrops to seek medical care immediately. Risk Statement: Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. Oz. No other lots are being recalled. Additionally, some product packaging is leaking or may otherwise be compromised. On March 3, Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. 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. Copyright 2023 CBS Interactive Inc. All rights reserved.
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