The Food and Drug Administration (FDA) has recently recalled three brands of eye drops, including one that has been linked to serious infections, vision loss and a death. First published on March 8, 2023 / 5:32 PM. Refresh Tears: Indications, Side Effects, Warnings - Drugs.com 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. This recall is being carried out to the retail level and is only for the specific lots listed above. 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. CDC Posts Update to Investigation Into Infections Linked to Eye Drops The products are distributed at the retail level by Walgreens. Refresh Plus Preservative Free Lubricant Eye Drops - 70ct Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. The CDC and FDA urge patients to immediately stop using the recalled eye drops even if they haven't experienced an adverse reaction. Additionally, some product packaging is leaking or may otherwise be compromised. The products are distributed at the retail level by CVS. The products are manufactured and labeled exclusively for Walgreens. "If we don't really need something, then we probably shouldn't be using it. The recall of Brimonidine Tartrate Ophthalmic Solution was initiated due to a manufacturing problem with the caps. Patients should not use eye-care products beyond the expiration date, as they may not be stable or sterile, Ma explained. 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. More eye drops are being recalled. The eyedrop-related strain of Pseudomonas aeruginosa has not previously appeared in the United States, the CDC said. 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. The product can be identified by the photos provided below. It can enter eye drops through contamination with environmental agents during handling, experts say. The recall came after the Centers for Disease Control and Prevention (CDC) began an investigation of a cluster of multistate bacterial infections it believed were associated with the tear drops. Two more people have died in the United States after being infected by Pseudomonas aeruginosa, a drug-resistant bacterium that has been linked to eyedrops, according to the Centers for Disease Control and Prevention, bringing the death count to three. 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. Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Nano Tears TF Clear Emollient Lubricant Gel Drops, Product Size: 15 mL, Nano Tears XP Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, Nano Tears XP Clear Emollient Lubricant Gel Drops, Product Size: 10 mL, Altaire Ofloxacin 0.3% Ophthalmic Solution, Product Size: 5 mL, ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF, Product Size: 7.5 mL, ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF, Product Size: 7.5 mL, ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, CVS Health Natural Tears Lubricant Eye Drops Preservative Free, Product Size: 0.6 mL x 32 ct, CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Product Size: 15 mL, CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Product Size: 30 mL, CVS Health Dry Eye Relief Eye Drops, Product Size: 15 mL, CVS Health Dry Eye Relief Eye Drops, Product Size: 30 mL, CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Product Size: 0.6 mL x 60 ct, CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Product Size: 0. REFRESH DIGITAL lubricant eye drops act fast to relieve eye dryness that may be due to digital device use. 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. EzriCare Artificial Tears Lubricant Eye Drop. 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. 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. Risk Statement: Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. 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. 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. ICE Limitations. 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 FDA Alerts below may be specifically about Refresh Plus or relate to a group or class of drugs which include Refresh Plus. refresh plus eye drops recall - Los Feliz Ledger 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. Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.) Preservative-free drops come in disposable single-use vials. In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. 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. 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. If youve used Ezricare and Delsam Pharmas Artificial Tears, look out for symptoms including yellow, green or clear discharge from the eye; eye pain or discomfort; redness of the eye or eyelid; a sensation that there is something in your eye; increased sensitivity to light; and blurry vision, according to the CDC. There have not been reports of illness or infection related to the product. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. 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,. 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. Global Pharma Healthcare Issues Voluntary Nationwide Recall of In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. Pharmedica on Friday said it is recalling two lots of Purely Soothing 15% MSM Drops due to problems that could result in blindness." Here's what you should know. 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. Anyone who has issues with any of the recalled eye drops can file a report with the F.D.A. For more information about drug recalls, visit the FDA website. 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. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. The drops were manufactured in Arizona. 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. As far as products and brands that remain on the market and are not under recall, he advised patients to "stick to the big brands that you trust." Patients who suffered infections of Pseudomonas aeruginosa reported using more than 10 brands of artificial tears, but none as often as EzriCare, according to the CDC. Call your doctor for medical advice about side effects. Oz. Most Facebook users can now claim settlement money. Other steps to prevent eye infections include making sure to wash your hands before touching your eyes or eye drops. Here's what you need to know about the flurry of eye drop recalls The C.D.C. Health officials said the outbreak is linked to using artificial tears. Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. The Centers for Disease Control and Prevention has warned people to stop using two brands of eye drops that have been linked to a drug-resistant strain of bacteria. Patients without symptoms do not need to undergo testing. The notice for the EzriCare and Delsam eye drops is here, and the notice for the Global Pharma eye ointment is here. Dr. Starr and Dr. Tylka both emphasized that, while the recalls were worrying, eye drops are generally safe. People who have used these artificial tears and who have symptoms of an eye infection should see a doctor immediately, the C.D.C. 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. Apotex is recalling six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% - prescription eye drops used to treat open-angle glaucoma or ocular hypertension. Anyone can read what you share. The CDC instructs those who are experiencing such symptoms and have used either of the two eyedrops to seek medical care immediately. They tend to be gentle on the eyes and can be used more frequently throughout the day.. The people who were sickened most commonly reported using EzriCare brand eye drops, while some patients used multiple brands. 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. 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.