Weeks later, two other types of eye drops were recalled because they posed a different kind of contamination risk. 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. 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. 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. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. The Apotex Brimonidine Tartrate notice is here and the Pharmedica Purely Soothing notice is here. Updated on: March 24, 2023 / 10:49 AM 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. 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. 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. Allergan recalls Refresh, FML, Blephamide eye drops Oz. Using contaminated artificial tears increases the risk of eye infections that could result in blindness or serious illness, Novack said. Pharmacology, adverse reactions, warnings and side effects. 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. TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. 1-2 drops in affected eye(s . Global Pharma recalled eye drops in February after they were tied to a drug-resistant bacteria strain linked to at least three deaths. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. Last week, the FDA posted a separate recall announcement from Apotex recalling six lots of prescription eyedrops used to treat a form of glaucoma. Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.) Pseudomonas aeruginosa is an aggressive bacterium that is found all over the environment, including in water, soil and human waste. What to Know About the Recent Eye Drop Recalls - New York Times At least four eyedrop products have been recalled recently. Ma specializes in ocular surface diseases diseases that damage the surface layers of the eye. Here's what you should know. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. First Republic Bank seized by regulators, then sold to JPMorgan Chase, Reward offered as manhunt for Texas shooting suspect reaches "dead end", Louisiana's health care deserts put women, babies at risk, doctors say, Second convoy of U.S. citizens fleeing Khartoum arrives at Port Sudan, ISIS chief killed by Turkey's intelligence agency, Erdogan says, How a tall Texan became an unlikely Australian rules football star, General Mills issues Gold Medal flour recall over salmonella concerns, Investors sue Adidas over Kanye West Yeezy deal, Shaquil Barrett's 2-year-old daughter dies in drowning accident, Three deaths linked to recalled eye drops, Health officials give new warnings about contaminated eye drops. Read on to learn more about a current list of recalled eye drops and symptoms of bacterial eye infections to consider. In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. The company said it launched the recall after finding cracks in a handful of bottle caps. 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. Pharmaceutical firmPharmedica USA on Marchrecalled two lots of "Purely Soothing, 15% MSM Drops," also over sterility concerns. If you are using any of these specific products, stop, said Gary D. Novack, a professor at UC Davis Health. 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. 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. 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. All About Vision does not provide medical advice, diagnosis or treatment. "Ask your eye doctor whether you really need them," Agus said. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. 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. 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,. 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, . Product was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. The companies involved in the recalls are Phoenix-based Pharmedica and Florida-based Apotex. 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. 5 of the best gel eye drops - Medical News Today Refresh Relieva: Indications, Side Effects, Warnings - Drugs.com There have not been reports of illness or infection related to the product. To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product. Powered and implemented by FactSet. Purely Soothing, 15% MSM Drops were recalled due to non-sterility. 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. Severe eye infections may often go ignored or misdiagnosed without clinical care, and left untreated, could cause life-threatening complications, especially with drug-resistant strains of bacteria like the one being traced by CDC officials. current good manufacturing practice (CGMP), www.accessdata.fda.gov/scripts/medwatch/index.cfm. 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. Pharmedica "Purely Soothing, 15% MSM Drops." 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. What do the numbers on your eyeglass frames mean? Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. These drops are used to treat eye irritation and swelling. The initial recall included Ezri Care Artificial Tears Lubricant Eye Drops and Desam Pharma Artificial Tears Lubricant Eye Drops. 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. 6 of the best eye drops for dry eyes - Medical News Today The drops were manufactured in Arizona. 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. No other lots are being recalled. 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. 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. Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. They tend to be gentle on the eyes and can be used more frequently throughout the day.. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. The C.D.C. Try these 6 ways to slow memory decline and lower dementia risk. 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. Patients who have used recalled eye drops should assess if they have any of the following symptoms commonly associated with eye infections: Patients with any signs of infection should immediately contact their health care provider for evaluation and treatment. REFRESH PLUS Lubricant Eye Drops instantly lubricates and moisturizes the eyes, resulting in temporary relief for mild symptoms of eye dryness. 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 more companies have since recalled eye drops. 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. The Phoenix-based company said consumers should immediately stop using the drops and return them to the place they were purchased. 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. Here's what you need to know about the flurry of eye drop recalls Pseudomonas aeruginosa can spread from one person to another through contaminated hands, equipment or surfaces, according to the CDC. 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. Delsam Pharma Artificial Tears Lubricant Eye Drops. Why Trust Us? Best for LASIK dryness: Refresh Plus Lubricant Eye Drops. 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. Refresh Plus ophthalmic (eye): Uses, Side Effects, Interactions - WebMD Over-the-counter medical products aren't as closely regulated as prescription drugs, noted CBS News medical contributor Dr. David Agus. 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. 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. EzriCare Artificial Tears were recalled after the CDC linked them to serious infections in multiple states. 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. Here are three ways to improve sleep. It has . Teva Pharmaceuticals have set up a recall hotline at 888-838-2872 for shoppers who have additional questions. 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. The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. Altaire Pharmaceuticals issued voluntary recalls for eye drops and ointments sold at CVS, Walgreens, Walmart and through Perrigo and others. All About Vision and AllAboutVision.com are registered trademarks of AAV Media, LLC. Don't use these eyedrops: List of recalled eyedrops 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.
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