They include EzriCare and Delsam Pharmas Artificial Tears, which have been associated with the bacterial infection. 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. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. Best for severe dry eye symptoms: GenTeal Lubricant Eye Gel. 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. 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. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death. TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. Elizabeth Connick, professor of medicine and immunobiology at the University of Arizona, said that the bacterium secretes proteins that can destroy the clear tissue at the front of the eye the cornea and allows it to invade the eye. Refresh Uses, Side Effects & Warnings - Drugs.com Well+Being shares news and advice for living well every day. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. Accutome Accu-WASHNDC# 63448-411-04 Product Size: 4 FL. The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. 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. 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. The product can be identified by the photos provided below. Jul 16, 2019 | Audience: Consumer, Health Professional, Pharmacy, Jul 15, 2019 | Audience: Consumer, Health Professional, Pharmacy, Jul 10, 2019 | Audience: Consumer, Health Professional, Pharmacy, Jul 5, 2019 | Audience: Consumer, Health Professional, Pharmacy, Jul 3, 2019 | Audience: Consumer, Health Professional, Pharmacy, Sep 8, 2013 | Audience: Consumer, Eye Care, Pharmacy, Patient, Health Professional. Symptoms associated with bacterial eye infections can include a wide array of eye-related discomfort and pain, including yellow, green or clear discharge; redness of the eye or eyelid; increased light sensitivity; consistent blurry vision; as well as an unshakable inner-eye irritation that feels like an itch, according to CDC officials. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product. Are Systane Ultra eye drops right for you. REFRESH PLUS is preservative-free which means it's great for sensitive eyes and can be used after LASIK or other eye surgeries. Pseudomonas aeruginosa tends to cause problems in places where immune responses are blunted, Robert T. Schooley, distinguished professor of medicine in the division of infectious diseases and global public health at the University of California at San Diego, previously told The Post. Delsam Pharma Artificial Tears Lubricant Eye Drops. Allergan recently issued a voluntary U.S. recall of its Refresh Lacri-Lube, Refresh P.M., FML (fluorometholone ophthalmic ointment) 0.1%, and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment) 10%/0.2% due to customer complaints of small black particles at the time of use. The CDC instructs those who are experiencing such symptoms and have used either of the two eyedrops to seek medical care immediately. Refresh Tears: Indications, Side Effects, Warnings - Drugs.com The institution also determined the bacteria is resistant to many antibiotics. Altaire ships the products labeled for Wal-Mart only to Wal-Mart. 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. 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. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. A Retail Level recall is limited to product lots currently in inventory at the chain store. All About Vision does not provide medical advice, diagnosis or treatment. 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. Oz. 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. Refresh Plus Preservative Free Lubricant Eye Drops - 70ct As of March 14, 68 patients across 16 states were found to have contracted the bacteria, known as Pseudomonas aeruginosa. Here's what you need to know about the flurry of eye drop recalls March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. More than five eye drop brands have launched recalls while health officials investigate a serious bacterial outbreak linked to blindness, eye loss and three deaths. Don't use these eyedrops: List of recalled eyedrops Patients should not use eye-care products beyond the expiration date, as they may not be stable or sterile, Ma explained. "Patients reported over 10 different brands of artificial tears and some patients used multiple brands," the CDC indicated. It can enter eye drops through contamination with environmental agents during handling, experts say. Ma specializes in ocular surface diseases diseases that damage the surface layers of the eye. 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. 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. UC Davis Health experts share what you need to know. Altaire ships the products labeled for CVS only to CVS. The Phoenix-based company said consumers should immediately stop using the drops and return them to the place they were purchased. Best for nighttime relief . TO DATE, ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATION RESULTS, INCLUDING IN-HOUSE AND THIRD-PARTY STERILITY TESTING, FOR THESE PRODUCTS. March 7, 2023 -- Two manufacturers of eyedrops have recalled products over fears about contamination and sterility. This flurry of recalls may have you second-guessing your trusted source of dry-eye relief, but there are significant differences among the recalls and plenty of steps you can take to stay safe. Oz. 2023 CBS Interactive Inc. All Rights Reserved. Another manufacturer,Apotex, on March 1 recalled six lots of its own brand of glaucoma drops, called "Brimonidine Tartrate Ophthalmic Solution, 0.15%," which is for patients with open-angle glaucoma or ocular hypertension. He said that when he accidentally hits his eyelid or eyelashes with the bottle tip, he considers the bottle contaminated and either resterilizes it or replaces it. TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. These Recalled Eye Drops Have Been Linked To Serious Infections And One 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. Teva Pharmaceuticals have set up a recall hotline at 888-838-2872 for shoppers who have additional questions. Are contact lenses a good choice for kids? According to the Associated Press, a patient in Los Angeles County, California, who had seen an ophthalmologist in the spring of 2022 developed an eye infection. 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. In January, testing confirmed the Florida cases were caused by the same bacteria strain as cases in California, Connecticut and Utah. In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. Anyone experiencing symptoms and who have used either of the two branded eye drops recently should seek immediate emergency medical care. Eyeglass temples: How do you know if they're the right length? 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. Refresh Plus ophthalmic (eye): Uses, Side Effects, Interactions - WebMD Get browser notifications for breaking news, live events, and exclusive reporting. 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.). 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. 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. Refresh Plus: Indications, Side Effects, Warnings - Drugs.com For any questions regarding product returns, contact GENCO at 877-674-2087 from 7 a.m. to 5 p.m. CST. 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. In January, the Centers for Disease Control and Prevention and the Food and Drug Administration warned people to stop using EzriCare Artificial Tears and Delsam Pharmas Artificial Tears after the eye drops were linked to a drug-resistant strain of the bacteria Pseudomonas aeruginosa. Its also important to check the expiration date. No other lots are being recalled. 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. Hearst Magazine Media, Inc. All Rights Reserved. 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. CDC: Eyedrops sold at Walmart, other stores linked to infections - NBC News 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. Delsam Pharma Artificial Eye Ointment. 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. The recall affects nearly 2,900 bottles, according to the company. On March 3, Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. 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. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. 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. One person died and at least five others had permanent vision loss. 5 of the best gel eye drops - Medical News Today Call your doctor for medical advice about side effects. Oz. As a subscriber, you have 10 gift articles to give each month. What do the numbers on your eyeglass frames mean? Refresh Plus Lubricant Eye drops instantly moisturizes and relieves dry, irritated eyes with a fast-acting, long-lasting formula for sensitive eyes that has many of the same healthy qualities as your own natural tears. Copyright 2023 CBS Interactive Inc. All rights reserved. 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. He said that one of the bottles was from a customer or consumer complaint and the other three were found in retained samples products that the F.D.A. Legal Statement. Here are three ways to improve sleep. The UC Davis Eye Center has not seen any cases linked to the EzriCare drops, but infections have been reported in 12 states, including California. The drops were manufactured in Arizona. Which Eye Drops Are Being Recalled? 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. / MoneyWatch. 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. ActivEyes Nighttime Lub Eye Ointment Preservative Free, Product Size: 3.5 g, Altaire Altacaine Solution, Product Size: 15 mL, ActivEyes Altachlore Ointment, Product Size: 3.5 gram, ActivEyes Altachlore Solution, Product Size: 15 mL, ActivEyes Altalube Ointment, Product Size: 3.5 gram, Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Product Size: 2.5 mL, Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Product Size: 5 mL, Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Product Size: 10 mL, Altaire Diclofenac Sodium Solution 1%, Product Size: 2.5 mL, Altaire Diclofenac Sodium Solution 1%, Product Size: 5 mL, Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution, Product Size: 5 mL, NanoTears HA PF Multi Dose Lubricant Gel Drops, Product Size: 10 mL, Nano Tears MO Clear Emollient Mineral Oil Lipids, Product Size: 10 mL, Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Product Size: 10 mL, Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack: 2 x 10 mL, Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose, Product Size: 7.5 mL.
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