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. Shop Plus Lubricant Eye Drops - Value Size and read reviews at Walgreens. Both companies said the recalls were conducted in consultation with the FDA. Brimonidine Tartrate Ophthalmic Solution, 0.15%. 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 two lots . 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. Market data provided by ICE Data Services. Two specific eye drop products have been expressly linked to the current Pseudomonas aeruginosa outbreak. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets. requires a company to keep back. Pseudomonas aeruginosa, which occurs naturally in the environment, can spread to humans who are exposed to contaminated water or soil. 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. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. 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 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 has determined these issues indicate a lack of sterility assurance. 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. 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. Turn on desktop notifications for breaking stories about interest? Global Pharma on February 24 alsorecalledone batch of a product distributed by Delsam Pharma,"Artificial Eye Ointment," again due to possible microbial contamination. ET. Select eye drops have been recalled over concerns the products may not be sterile, notices posted on the Food & Drug Administration website show. More eye drops are being recalled. No other lots are being recalled. 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. The products are distributed at the retail level by Walgreens. Pharmedica on Friday said it is recalling two lots of Purely Soothing 15% MSM Drops due to problems that could result in blindness." 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 products are distributed at the retail level by Wal-Mart. 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. 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. Original strength formula is designed to act like your own natural tears. 2023 CBS Interactive Inc. All Rights Reserved. You should avoid kava and 9 other risky dietary supplements. 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. Best preservative-free eye drops: Refresh Optive Mega-3. 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. The Phoenix-based company said consumers should immediately stop using the drops and return them to the place they were purchased. Refresh Plus Preservative Free Lubricant Eye Drops - 70ct Delsam Pharma "Artificial Eye Ointment." 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. Change in eyesight, eye pain, or very bad eye irritation. EzriCare and Delsam Pharma "Artificial Tears Lubricant Eye Drops." Legal Statement. The two other eye drop recalls were not linked to the bacteria outbreak. Both formulas protect tears from evaporating due to incomplete blinking from screen time. UC Davis Health experts share what you need to know. The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. CDC: Eyedrops sold at Walmart, other stores linked to infections - NBC News Pseudomonas aeruginosa can spread from one person to another through contaminated hands, equipment or surfaces, according to the CDC. 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. Are contact lenses a good choice for kids? "Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating whether contamination may have occurred during manufacturing," per current CDC reports. Clear Eyes Redness Relief (Little Drug)
, Product Size: 0.2 oz. Sign up for our newsletter to get tips directly in your inbox. 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. Bacteria in recalled eye drops linked to cases of vision loss - CNN Oz. The over-the-counter drops are designed to treat eye irritation. Clear Eyes Once Daily, Eye Allergy . No other lots are being recalled. 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. Refresh Plus Lubricant Eye drops instantly moisturizes and relieves dry, irritated eyes with a fast-acting, long-lasting formula for sensitive eyes that has many of the same healthy qualities as your own natural tears. Pharmaceutical firmPharmedica USA on Marchrecalled two lots of "Purely Soothing, 15% MSM Drops," also over sterility concerns. To use eye drops safely, Dr. Tylka said that people should use their own bottle and make sure it has not expired. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. We may earn commission from links on this page, but we only recommend products we back. We may earn commission from links on this page, but we only recommend products we back. Change in eyesight, eye pain, or very bad eye irritation. The drops might be contaminated and could be a source of an outbreak of drug-resistant infections that may lead to vision loss. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products. Oz. 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.). This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Patients who have previously used potentially unsafe products should contact their doctors and ask for a safe substitute. Altaire takes its mission of customer safety and providing quality products very seriously. 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. If you have "artificial tears" eye drops in your home, check to make sure you don't have one of these recently recalled products. Allergan recalls Refresh, FML, Blephamide eye drops For any questions regarding product returns, contact GENCO at 877-674-2087 from 7 a.m. to 5 p.m. CST. Apotex said in an email that the eyedrops were manufactured in Canada. The C.D.C. Weeks later, two other types of eye drops were recalled because they posed a different kind of contamination risk. 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. 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 products are manufactured and labeled exclusively for Wal-Mart. 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. Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. Pharmedica USA LLC is advising customers to immediately stop using the product and return it to the place of purchase. 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 what you should know. What Happened To Refresh Repair Eye Drops? - On Secret Hunt 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. 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. 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. 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 product is being recalled due to non-sterility. 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. 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. Additionally, some product packaging is leaking or may otherwise be compromised. And symptoms triggered by this particular bacterial infection may start presenting usually within 12 to 24 hours, per published research. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Most of the time, they shouldnt cause alarm. Delsam Pharma Artificial Tears Lubricant Eye Drops. Each notice has details on which batch of each product was affected. TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. 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. Uses Before taking Warnings The product was distributed nationwide in the United States, and by Delsam through internet retail sites. 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. Powered and implemented by FactSet. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. They include EzriCare and Delsam Pharmas Artificial Tears, which have been associated with the bacterial infection. Pharmedica is recalling its Purely Soothing 15% MSM Drops meant to treat eye irritation. EzriCare Artificial Tears were recalled after the CDC linked them to serious infections in multiple states. 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. There's no indication the latest recalls are related to those products. OZ. An Apotex vice president, Jordan Berman, said in an email that the company had seen only four bottles with cracked caps. 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. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. The drops were manufactured in Arizona. Altaire ships the products labeled for Wal-Mart only to Wal-Mart. 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. The Eye Center team aims to transform vision care and develop cures for blinding eye diseases, from cornea to cortex. Sign up for the Well+Being newsletter, your source of expert advice and simple tips to help you live well every day. 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. 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 notice for the EzriCare and Delsam eye drops is here, and the notice for the Global Pharma eye ointment is here. The eyedrop-related strain of Pseudomonas aeruginosa has not previously appeared in the United States, the CDC said. 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. 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. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product. The products are manufactured and labeled exclusively for Walgreens. refresh plus eye drops recall - Los Feliz Ledger 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. The AP is solely responsible for all content. Tilt your head back, look up, and pull down the lower eyelid to make a pouch. As of March 14, the CDC had identified 68 patients across 16 states who had been infected infected by Pseudomonas aeruginosa. Teva Pharmaceuticals have set up a recall hotline at 888-838-2872 for shoppers who have additional questions. Refresh Plus: Indications, Side Effects, Warnings - Drugs.com 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.
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