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. 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. Eye Drops Recall 2023: List of Brands Linked to Potential Infections ET. 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. NDC#: 59390-175-18 Product Size: 1 Fl. 2000-2023 AAV Media, LLC. 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. 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. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Turn on desktop notifications for breaking stories about interest? As the FDA notes, "administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.". 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. Here's how. 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. For any questions regarding product returns, contact GENCO at 877-674-2087 from 7 a.m. to 5 p.m. CST. 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. Refresh Plus Lubricant Eye Drops - Value Size | Walgreens Global Pharma on February 24 alsorecalledone batch of a product distributed by Delsam Pharma,"Artificial Eye Ointment," again due to possible microbial contamination. Bacteria in recalled eye drops linked to cases of vision loss - CNN Is there a recall on Refresh eye drops? "Patients reported over 10 different brands of artificial tears and some patients used multiple brands," the CDC indicated. via F.D.A. 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. 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. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. FDA recalls 3 brands of eye drops. This over-the-counter product is being recalled due to non-sterility. CDC issued an alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA. said. An Apotex vice president, Jordan Berman, said in an email that the company had seen only four bottles with cracked caps. To safely apply eye drops, she said, people should use their nondominant hand to gently tug on the lower eyelid, look up slightly, and then, with the dominant hand, put that little drop in that lower cul-de-sac in the eyelid area.. Consumers are advised to stop using the following brands and return them to the place of purchase. Recalled eyedrops causing blindness: What to know about drug-resistant 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. Zee Krstic is a health editor for Good Housekeeping, where he covers health and nutrition news, decodes diet and fitness trends and reviews the best products in the wellness aisle. Copyright 2023 CBS Interactive Inc. All rights reserved. In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. 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. It was later expanded to include Delsam Pharma Artificial. The products are manufactured and labeled exclusively for Wal-Mart. He has written about food and dining for Time, among other publications. The notice for the EzriCare and Delsam eye drops is here, and the notice for the Global Pharma eye ointment is here. 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. Since then, several additional eye products have been taken off shelves, though not all are related to the bacterial infection. If you have any of these symptoms, please see an eye care professional, Novack said. Using contaminated artificial tears increases the risk of eye infections that could result in blindness or serious illness, Novack said. The people who were sickened most commonly reported using EzriCare brand eye drops, while some patients used multiple brands. Oz. The company did not specify how many bottles were affected or how the bottles became not sterile. 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, . 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. Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately. If you are using any of these specific products, stop, said Gary D. Novack, a professor at UC Davis Health. 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 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 outbreak has also been connected to eight recent reports of vision loss and four reports of enucleation, or surgical removal of an eyeball. 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. Call your doctor for medical advice about side effects. The CDC instructs those who are experiencing such symptoms and have used either of the two eyedrops to seek medical care immediately. A severe eye infection can feel similar to less threatening conditions such as dry eye disease and other autoimmune or inflammatory diseases of the eyes, experts caution. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death. Clear Eyes Once Daily, Eye Allergy . NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free. Waking up frequently at night can harm your health. Local health officials identified several more cases in subsequent months, with patients reporting eyes inflamed with heavy yellow pus that obscured most of the pupil. The Phoenix-based company said consumers should immediately stop using the drops and return them to the place they were purchased. As a subscriber, you have 10 gift articles to give each month. I would encourage all people out there who take eye drops to continue using them, of course making sure that theyre not using any of these that are recalled, said Dr. Christopher Starr, a clinical spokesman for the American Academy of Ophthalmology. The products are distributed at the retail level by Wal-Mart. The two other eye drop recalls were not linked to the bacteria outbreak. Brimonidine Tartrate Ophthalmic Solution, 0.15%. 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. ET. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. What are the symptoms of eye infection to watch out for? Global Pharma, which makes EzriCare and Delsam Pharmas eye drops, recalled both products in February. The Eye Center team aims to transform vision care and develop cures for blinding eye diseases, from cornea to cortex.
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