The FDA has determined these issues indicate a lack of sterility assurance. 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. Uses Before taking Warnings But the flurry of recalls is leaving some regular users of the products wondering, are they safe? Brimonidine Tartrate Ophthalmic Solution, 0.15%. Apotex is recalling six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% - prescription eye drops used to treat open-angle glaucoma or ocular hypertension. In addition to the three deaths that are being traced back to tainted eye drops, CNN reports that federal officials have indicated that eight patients have developed blindness due to the outbreak. Both companies said the recalls were conducted in consultation with the FDA. 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. Pharmedica on Friday said it is recalling two lots of Purely Soothing 15% MSM Drops due to problems that could result in blindness." 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. 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. The products are distributed at the retail level by Walgreens. Global Pharma Healthcare said in a a statementthat consumers who use the contaminated eye drops could go blind. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The F.D.A. The over-the-counter drops are designed to treat eye irritation. What do the numbers on your eyeglass frames mean? 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. 24/7 coverage of breaking news and live events. Altaire ships the products labeled for Walgreens only to Walgreens. 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. Here's what you should know. Customers have been advised to immediately stop using the drops. Are contact lenses a good choice for kids? Available for Android and iOS devices. Updated on: March 24, 2023 / 10:49 AM 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. 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. On March 1, Apotex recalled prescription eye drops used to reduce eye pressure in people with glaucoma or ocular hypertension. 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. The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. Medicaid: Eligibility and Vision Benefits. To use eye drops safely, Dr. Tylka said that people should use their own bottle and make sure it has not expired. 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. 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. 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. 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. Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. First published on March 8, 2023 / 5:32 PM. 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. Global Pharma Healthcare Artificial Eye Ointment, UC Davis Health leads $2M program to improve eye care for people with diabetes, UC Davis Health opens doors to new state-of-the-art eye care facility in Sacramento, Eye Center first to test microshunt in children with refractory childhood glaucoma. Global Pharma, which makes EzriCare and Delsam Pharmas eye drops, recalled both products in February. REFRESH PLUS prescription and dosage sizes information for physicians and healthcare professionals. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product. ActivEyes Nighttime Lub Eye Ointment Preservative Free, NDC#: 59390-184-50 Product Size: 3.5 gram, NDC#: 59390-198-50 Product Size: 3.5 gram, Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution. Product Description: Clear Eyes Redness Relief (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. Best preservative-free: Systane Ultra Lubricant Eye Drops. The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. People who have used these artificial tears and who have symptoms of an eye infection should see a doctor immediately, the C.D.C. There have been a total of three deaths linked back to exposure through eye drops specifically, with federal investigators indicating that they may soon learn of additional illnesses. The FDA and CDC are advising patients to stop using EzriCare Artificial Tears, an over-the-counter brand of eye drops. A Retail Level recall is limited to product lots currently in inventory at the chain store. Both formulas protect tears from evaporating due to incomplete blinking from screen time. 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. 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. 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. Pseudomonas aeruginosa is an aggressive bacterium that is found all over the environment, including in water, soil and human waste. Oz. The two lots . Using contaminated artificial tears increases risk of eye infections that could result in blindness or death. BACKGROUND: Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box. 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. has also warned people to stop using an eye ointment manufactured by Global Pharma because of possible contamination. Teva Pharmaceuticals have set up a recall hotline at 888-838-2872 for shoppers who have additional questions. The CDC and FDA urge patients to immediately stop using the recalled eye drops even if they haven't experienced an adverse reaction. ET. No other lots are being recalled. 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. No other lots are being recalled. 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. 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. Best for use with . The products are manufactured and labeled exclusively for CVS Health. Purely Soothing, 15% MSM Drops were recalled due to non-sterility. 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. Shop Plus Lubricant Eye Drops - Value Size and read reviews at Walgreens. Select eye drops have been recalled over concerns the products may not be sterile, notices posted on the Food & Drug Administration website show. Oz. February 23, 2023 --Global Pharma Healthcare is voluntarily recalling Batch No. Most of the time, they shouldnt cause alarm. REFRESH PLUS Lubricant Eye Drops instantly lubricates and moisturizes the eyes, resulting in temporary relief for mild symptoms of eye dryness. 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. Additionally, some product packaging is leaking or may otherwise be compromised. 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.). The company also provided a phone number and website for people to request a recall/return packet.. The Apotex Brimonidine Tartrate notice is here and the Pharmedica Purely Soothing notice is here. Dr. Starr and Dr. Tylka both emphasized that, while the recalls were worrying, eye drops are generally safe. They include EzriCare and Delsam Pharmas Artificial Tears, which have been associated with the bacterial infection. Altaire Pharmaceuticals issued voluntary recalls for eye drops and ointments sold at CVS, Walgreens, Walmart and through Perrigo and others. 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. 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. Amazon Marketplace, Etc.). Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. Novack is a clinical pharmacologist with decades of experience in ophthalmic product development. 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. 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. 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. 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. Eye drops recall at Walmart, CVS, Walgreens Altaire Pharmaceuticals issued voluntary recalls for eye drops and ointments sold at CVS, Walgreens, Walmart and through Perrigo. via F.D.A. New mortgage rules could lead to some homebuyers paying more, Dylan Mulvaney breaks silence on Bud Light backlash in new video, First Republic clients pulled $100 billion in deposits, Death toll climbs in outbreak linked to recalled eye drops as new treatment identified. The FDA has determined these issues indicate a lack of sterility assurance. 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 Eye Ointment." 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. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. Look down and gently . Most Facebook users can now claim settlement money. The product can be identified by the labels below. Last updated on Dec 27, 2022. 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. The outbreak has also been connected to eight recent reports of vision loss and four reports of enucleation, or surgical removal of an eyeball. 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. FDA recalls 3 brands of eye drops. 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. March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. 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. 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. 1-2 drops in affected eye(s . 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. More eye drops are being recalled. 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.". Try these 6 ways to slow memory decline and lower dementia risk. 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. ICE Limitations. The hospital that reported the first infection determined it was caused by the Pseudomonas aeruginosa bacteria, which can cause infections in the blood, lungs or other parts of the body. Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness. current good manufacturing practice (CGMP), www.accessdata.fda.gov/scripts/medwatch/index.cfm. 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. Product Description: Clear Eyes Redness Relief (Select Corp)UPC#: 6-55708-01039-6 Product Size: 0.2 FL. Eating like a centenarian can help you live a longer life. 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. We may earn commission from links on this page, but we only recommend products we back. Altaire ships the products labeled for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige only to Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige, respectively. Best for LASIK dryness: Refresh Plus Lubricant Eye Drops. The Food and Drug Administration posted separate recall notices for certain eyedrops distributed by Pharmedica and Apotex after the companies said they are voluntarily pulling several lots of their products from the market. 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. 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. 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 products are distributed at the retail level by Wal-Mart. All About Vision does not provide medical advice, diagnosis or treatment. Ma specializes in ocular surface diseases diseases that damage the surface layers of the eye. Contact an eye doctor if you need medical attention. 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. The institution also determined the bacteria is resistant to many antibiotics. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 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. The company did not specify how many bottles were affected or how the bottles became not sterile. 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. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. On January 20, the CDC told doctors to avoid recommending the EzriCare product. Its also important to check the expiration date. 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. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. He also urged consumers to consider whether they really need to use eye drops. 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. 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. CVS Health Natural Tears Lubricant Eye Drops Preservative Free, Item#: 538397 Product Size: 0.6 mL x 32 ct, CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 495334 Product Size: 0.6 mL x 60 ct, Item#: 994883 Product Size: 0. Eight people also have lost their vision and four have had their eyeballs removed, according to the Centers for Disease Control and Prevention.

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