refresh plus eye drops recall

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. Since then, several additional eye products have been taken off shelves, though not all are related to the bacterial infection. The content on this site is for informational purposes only. Most Facebook users can now claim settlement money. 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. Reboot. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. 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. 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. Clear Eyes Redness Relief (Select Corp) , Product Size: 0.2 oz. Anyone experiencing symptoms and who have used either of the two branded eye drops recently should seek immediate emergency medical care. For any questions regarding product returns, contact GENCO at 877-674-2087 from 7 a.m. to 5 p.m. CST. The two lots . July 16, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold by Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige Brands Inc., during the time period as indicated in the tables below. Angelika Warmuth/Picture-Alliance-DPA, via Associated Press, The manufacturer of EzriCare Artificial Tears said it was recalling the product out of an abundance of caution.. These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile. In 2017, the United States saw about 2,700 deaths related to Pseudomonas aeruginosa and 32,600 cases in hospitalized patients, according to CDC estimates. 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. The company did not specify how many bottles were affected or how the bottles became not sterile. 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. If a patient experiences eye pain, swelling, ocular discomfort or irritation after using any of the recalled products, Allergan says the patient should contact a healthcare provider. 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. Customers with questions regarding this recall can contact 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. Pharmaceutical firmPharmedica USA on Marchrecalled two lots of "Purely Soothing, 15% MSM Drops," also over sterility concerns. 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. There have not been reports of illness or infection related to the product. The product can be identified by the photos provided below. Why Trust Us? Well+Being shares news and advice for living well every day. 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. Best for extended relief: Blink Tears Lubricating Eye Drops. Do Not Sell or Share My Personal Information. In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. The two other eye drop recalls were not linked to the bacteria outbreak. The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles. Clear Eyes Once Daily, Eye Allergy . via F.D.A. News provided by The Associated Press. Oz. 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. This recall is being carried out to the retail level and is only for the specific lots listed above. As a subscriber, you have 10 gift articles to give each month. Written by Jay Croft. 6 mL x 30 ct, CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Product Size: 0.6 mL x 30, CVS Health Lubricating Gel Drops for Anytime Use, Product Size: 10 mL, CVS Health Overnight Lubricating Eye Ointment, Product Size: 3.5 gram, CVS Health Lubricant Eye Ointment, Product Size: 3.5 gram, CVS Health Extra Strength Lubricant Gel Drops, Product Size: 15 mL, CVS Health Extra Strength Lubricant Gel Drops Twin Pack, 2 x 15 mL, CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Product Size: 15 mL, CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack, Product Size: 2 x 10 mL, CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Product Size: 0.6 mL x 30ct, CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Product Size: 0.6 mL x 70ct, CVS Health Preservative Free Lubricant Eye Drops Advanced Relief, Product Size: 0.6 mL x 30, CVS Health Lubricant Eye Drops Advanced Relief, Product Size: 10 mL, CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Product Size: 0.6 mL x 24 ct, CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Product Size: 0.6 mL x 60 ct, CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief, Product Size: 30 mL, CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Product Size: 10 mL, CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack, Product Size: 2 x 10 mL, CVS Health Maximum Redness Relief Eye Drops, Product Size: 15 mL, CVS Health Redness Relief, Product Size: 15 mL, CVS Health Redness Relief, Product Size: 30 mL, CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Product Size: 15 mL, CVS Health Lubricant Eye Ointment Sensitive Formula, Product Size: 3.5 gram, Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment, Package Size: 3.5 gm, NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment, Package Size: 3.5 gm, NEO-POLYCIN HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment, Package Size: 3.5 gm, POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment, Package Size: 3.5 gm, Bacitracin Ophthalmic Ointment, Package Size: 3.5 gm, Sulfacetamide Sodium Ophthalmic Ointment, Package Size: 3.5 gm, Puralube Ophthalmic Ointment (Please note: Puralube is an OTC product), Package Size: 3.5 gm, Puralube Ophthalmic Ointment (Please note: Puralube is an OTC product), Package Size: 1 gm, FreshKote Lubricant Eye Drops , Product Size: 15 mL, Grandall Colirio Ojo De Aguila Eye Drops , Product Size: 15 mL, Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL, Grandall Oftal-Mycin Ophthalmic Ointment , Product Size: 3.5 gm, Natural Ophthalmics Ortho-K Thick Comfort Gel , Product Size: 15 mL, Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, Product Size: 15 mL, Natural Ophthalmics Ortho-K Thin Eye Drops, Product Size: 15 mL, Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, Product Size: 15 mL, Natural Ophthalmics Cataract Eye Drops with Cineraria, Product Size: 15 mL, Natural Ophthalmics Allergy Desensitization Eye Drops , Product Size: 15 mL, OCuSOFT Homatropine Hydrobromide Ophthalmic Solution 5%, Product Size: 5 mL, OCuSOFT Tetcaine Hydrochloride Ophthalmic Solution USP, 0. 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 three recent eye-drop recalls appear to be unrelated. "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. Copyright 2023 CBS Interactive Inc. All rights reserved. Dr. Barbara Tylka, an optometrist at the Mayo Clinic in Rochester, Minn., said that, in general, eye drops are safe to use and that many people need them to treat conditions such as dryness or irritation. 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 BELOW. Pickup & Same Day Delivery available on most store items. Dr. Starr and Dr. Tylka both emphasized that, while the recalls were worrying, eye drops are generally safe. An Apotex vice president, Jordan Berman, said in an email that the company had seen only four bottles with cracked caps. If it is truly bacterial, a direct eye exam will determine it, since there are certain clinical features we can see that would suggest bacteria and the degree of infection, Dave Patel, an ophthalmologist at the Mayo Clinic in Phoenix, told The Post. The drops have not been linked to illness, the company said, though it cautioned that using contaminated eye products can increase risk for infections that could result in blindness. Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness. Sign up for our newsletter to get tips directly in your inbox. Product Description: Clear Eyes Redness Relief (Select Corp)UPC#: 6-55708-01039-6 Product Size: 0.2 FL. If you have "artificial tears" eye drops in your home, check to make sure you don't have one of these recently recalled products. 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. Best for severe dry eye symptoms: GenTeal Lubricant Eye Gel. Contact an eye doctor if you need medical attention. 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. The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. 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. 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. 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. 1-2 drops in affected eye(s . 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. The drops were manufactured in Arizona. 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. Read on to learn more about a current list of recalled eye drops and symptoms of bacterial eye infections to consider. 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. No other lots are being recalled. For drops/gels, place the dropper directly over the eye and squeeze out 1 or 2 drops as needed. 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. REFRESH DIGITAL lubricant eye drops act fast to relieve eye dryness that may be due to digital device use. 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. No other lots are being recalled. ICE Limitations. The people who were sickened most commonly reported using EzriCare brand eye drops, while some patients used multiple brands. 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. Common side effects of Refresh may include: mild eye burning or irritation; itching or redness of your eyes; watery eyes; blurred vision; or sensitivity to light. The recall of Brimonidine Tartrate Ophthalmic Solution was initiated due to a manufacturing problem with the caps. 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. 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. Delsam Pharma Artificial Eye Ointment. We're recapping that information below. Ive continued to use eyedrops every day throughout this whole thing, Dr. Starr said. Over-the-counter medical products aren't as closely regulated as prescription drugs, noted CBS News medical contributor Dr. David Agus. No other lots are being recalled. The import alert prevents these products from entering the United States. For more information about drug recalls, visit the FDA website. 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 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. On Thursday, the maker of the eyedrops recalled them because of possible contamination. .css-lwn4i5{display:block;font-family:Neutra,Helvetica,Arial,Sans-serif;font-weight:bold;letter-spacing:-0.01rem;margin-bottom:0;margin-top:0;text-align:center;-webkit-text-decoration:none;text-decoration:none;}@media (any-hover: hover){.css-lwn4i5:hover{color:link-hover;}}@media(max-width: 48rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}@media(min-width: 40.625rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}@media(min-width: 48rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}@media(min-width: 64rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}8 Surprising Benefits of Cycling, 12 Potential Arcturus COVID Symptoms to Know, The Reason Why You Buy Things When You're Drunk, Heres the Real Reason Why You Get Toe Cramps, How Buccal Fat Removal Surgery Actually Works. 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. The FDA and CDC are advising patients to stop using EzriCare Artificial Tears, an over-the-counter brand of eye drops. You should avoid kava and 9 other risky dietary supplements. Best for digital eyestrain: Systane Gel Drops. Patients should not use eye-care products beyond the expiration date, as they may not be stable or sterile, Ma explained. 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. 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. 0.15% and were sold between last April through February. One person died and at least five others had permanent vision loss. 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. 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. If you have any of these symptoms, please see an eye care professional, Novack said. 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. Infections can present in ways such as keratitis, sepsis and respiratory and urinary tract infections. It has . 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. UC Davis Health experts share what you need to know. The company hasn't received any reports of injuries related to the drops. 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, . Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharmas Artificial Tears. Customers have been advised to immediately stop using the drops. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets. The Apotex Brimonidine Tartrate notice is here and the Pharmedica Purely Soothing notice is here. The notice for the EzriCare and Delsam eye drops is here, and the notice for the Global Pharma eye ointment is here. The company recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent because at least four bottle caps developed cracks, which could affect the products sterility. No infections have been associated with this over-the-counter product. On March 3, Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. The products are distributed at the retail level by CVS. Pseudomonas aeruginosa, which occurs naturally in the environment, can spread to humans who are exposed to contaminated water or soil. No other lots are being recalled. Try these 6 ways to slow memory decline and lower dementia risk. They include EzriCare and Delsam Pharmas Artificial Tears, which have been associated with the bacterial infection. Oz. These drops are used to treat eye irritation and swelling. Read on to learn which eye drops are being recalled and why. 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 frequency and color of poop can vary. 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. 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 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. 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. 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. Best preservative-free: Systane Ultra Lubricant Eye Drops. 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. 24/7 coverage of breaking news and live events. An additional four have had to have their eyeballs surgically removed to prevent further side effects or more serious symptoms. 2023 CBS Interactive Inc. All Rights Reserved. Waking up frequently at night can harm your health. Altaire has also requested that the labelers each perform a subrecall. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. 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. 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. 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. It can enter eye drops through contamination with environmental agents during handling, experts say. Product was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. The manufacturer, Global Pharma Healthcare, has issued a nationwide recall of the product. CDC issued an alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA. Anyone can read what you share. This over-the-counter product is being recalled due to non-sterility. 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. Sign up for our newsletter to get tips directly in your inbox. 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. 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. Two more companies have since recalled eye drops. . Consumers with questions regarding this recall can contact Pharmedica USA LLC by phone number at +1 (623) 698 - 1752 or e-mail address at osm@pharmedicausa.com Monday to Friday between the hours of 8:00 AM MST (AZ) and 5:00 PM MST (AZ).. 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 over-the-counter drops are designed to treat eye irritation. 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. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death. 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. 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. / MoneyWatch. Find an eyecare professional and book online in minutes!

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