Over-the-counter medical products aren't as closely regulated as prescription drugs, noted CBS News medical contributor Dr. David Agus. 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. What to Know About the Recent Eye Drop Recalls, https://www.nytimes.com/article/eye-drops-recall-explained.html. Its also important to check the expiration date. 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. It can enter eye drops through contamination with environmental agents during handling, experts say. The company hasn't received any reports of injuries related to the drops. Anyone who has issues with any of the recalled eye drops can file a report with the F.D.A. 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. Three people have died and eight patients reported vision loss, according to the agency. Pseudomonas aeruginosa can spread from one person to another through contaminated hands, equipment or surfaces, according to the CDC. Altaire Pharmaceuticals issued voluntary recalls for eye drops and ointments sold at CVS, Walgreens, Walmart and through Perrigo and others. Change in eyesight, eye pain, or very bad eye irritation. 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. The FDA has determined these issues indicate a lack of sterility assurance. Global Pharma recalled eye drops in February after they were tied to a drug-resistant bacteria strain linked to at least three deaths. UC Davis Health experts share what you need to know. No other lots are being recalled. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. Oz. Shop Plus Lubricant Eye Drops - Value Size and read reviews at Walgreens. ET. As of March 14, the CDC had identified 68 patients across 16 states who had been infected infected by Pseudomonas aeruginosa. Apotex "Brimonidine Tartrate Ophthalmic Solution, 0.15%." This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. People not experiencing symptoms do not need to test for possible infection, it says. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. The eyedrop-related strain of Pseudomonas aeruginosa has not previously appeared in the United States, the CDC said. Two more companies have since recalled eye drops. Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday Friday from 9 am 5 pm ET. The product was distributed nationwide in the United States, and by Delsam through internet retail sites. This recall is being carried out to the retail level and is only for the specific lots listed above. Product Description: Clear Eyes Redness Relief (Select Corp)UPC#: 6-55708-01039-6 Product Size: 0.2 FL. There are a few other eye drops and one other eye ointment that have been concurrently recalled in the same period as the two products above but not due to the same potential bacterial exposure. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Select eye drops have been recalled over concerns the products may not be sterile, notices posted on the Food & Drug Administration website show. 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. The initial recall included Ezri Care Artificial Tears Lubricant Eye Drops and Desam Pharma Artificial Tears Lubricant Eye Drops. Hearst Magazine Media, Inc. All Rights Reserved. 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. Find an eyecare professional and book online in minutes! Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Call your doctor for medical advice about side effects. "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. Heres what to know. Select one or more newsletters to continue. Contact an eye doctor if you need medical attention. Best for LASIK dryness: Refresh Plus Lubricant Eye Drops. 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. FDA recommended this recall due to the companys current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging. 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. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. 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. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 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. One person died and at least five others had permanent vision loss. The recall affects nearly 2,900 bottles, according to the company. 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. The FDA issued recall notices last week for eyedrops made . Original strength formula is designed to act like your own natural tears. Customers have been advised to immediately stop using the drops. He also urged consumers to consider whether they really need to use eye drops. ET. Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharmas Artificial Tears. 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. The drops might be contaminated and could be a source of an outbreak of drug-resistant infections that may lead to vision loss. 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. Two brands of eye drops have been pulled from shelves in January and February after they were linked to a drug-resistant bacteria strain that has caused at least three deaths and serious health issues in several others. 1-2 drops in affected eye(s . 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.). July 5, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Wal-Mart during the time period as indicated in the tables below. 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. 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. The C.D.C. Patients who have previously used potentially unsafe products should contact their doctors and ask for a safe substitute. REFRESH PLUS Lubricant Eye Drops instantly lubricates and moisturizes the eyes, resulting in temporary relief for mild symptoms of eye dryness. 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. 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. is used as an eye lubricant and to relieve dryness of the eyes. Prior to joining GH in 2019, Zee fostered a nutrition background as an editor at Cooking Light and is continually developing his grasp of holistic health through collaboration with leading academic experts and clinical care providers. The companies involved in the recalls are Phoenix-based Pharmedica and Florida-based Apotex. To use eye drops safely, Dr. Tylka said that people should use their own bottle and make sure it has not expired. 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. 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 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. On January 20, the CDC told doctors to avoid recommending the EzriCare product. "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. 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 . 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. Uses Before taking Warnings 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. 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. The products are distributed at the retail level by Wal-Mart. show all 21 brands Drug class: Ophthalmic lubricants and irrigations Medically reviewed by Drugs.com. 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. 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. 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. 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. Altaire ships the products labeled for Walgreens only to Walgreens. If you think you may have an eye infection, contact your eye care provider. 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. Product was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. 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. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. 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. Since then, several additional eye products have been taken off shelves, though not all are related to the bacterial infection. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. February 23, 2023 --Global Pharma Healthcare is voluntarily recalling Batch No. Additionally, some product packaging is leaking or may otherwise be compromised. 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. These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile. 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. 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. 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. If you have any of these symptoms, please see an eye care professional, Novack said. 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. The recall of Brimonidine Tartrate Ophthalmic Solution was initiated due to a manufacturing problem with the caps. There have been no drug safety reports related to negative health outcomes due to this product, Mr. Berman said. 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. CBS News' Alexander Tin and the Associated Press contributed to this report. The manufacturer, Global Pharma Healthcare, has issued a nationwide recall of the product. 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. 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 content on this site is for informational purposes only. Apotex is recalling six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% - prescription eye drops used to treat open-angle glaucoma or ocular hypertension. Pharmedica is recalling its Purely Soothing 15% MSM Drops meant to treat eye irritation. The products are distributed at the retail level by CVS. Delsam Pharmas NDC for this product is 72570-122-35, and its UPC code is 3 72570 012235 3. Pickup & Same Day Delivery available on most store items. 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. 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. Oz. 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. 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. Pharmacology, adverse reactions, warnings and side effects. 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. 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. The AP is solely responsible for all content. 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. 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. Tilt your head back, look up, and pull down the lower eyelid to make a pouch. Best for severe dry eye symptoms: GenTeal Lubricant Eye Gel. Well+Being shares news and advice for living well every day. Two specific eye drop products have been expressly linked to the current Pseudomonas aeruginosa outbreak. The products are manufactured and labeled exclusively for Wal-Mart. Infections can present in ways such as keratitis, sepsis and respiratory and urinary tract infections. Pharmedica warned that patients who use the contaminated eye drops can risk going blind, but the company said it has not received any reports of infection or illness related to its product. On March 3, Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. 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. Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level,. Waking up frequently at night can harm your health. While recalls are being implemented across the nation, cases thus far have been recorded in 16 states: California, Colorado, Connecticut, Florida, Illinois, Nevada, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, South Dakota, Texas, Utah, Washington and Wisconsin. 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. 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. 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. It has . No other lots are being recalled. 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. The people who were sickened most commonly reported using EzriCare brand eye drops, while some patients used multiple brands. ET. Change in eyesight, eye pain, or very bad eye irritation. 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.
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