"There's not much testing of safety on any of these things, so when something comes out it's because there were complaints, or in this case a drug-resistant bacteria was linked to a bunch of cases," he told CBS MoneyWatch. Common side effects of Refresh may include: mild eye burning or irritation; itching or redness of your eyes; watery eyes; blurred vision; or sensitivity to light. CBS News' Alexander Tin and the Associated Press contributed to this report. OZ. 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. This recall is being carried out to the retail level and is only for the specific lots listed above. The best way to find out if you have eye drops that were included in the recall is to review the recall notice provided by each company. 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. Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. The frequency and color of poop can vary. Oz. Other steps to prevent eye infections include making sure to wash your hands before touching your eyes or eye drops. Weeks later, two other types of eye drops were recalled because they posed a different kind of contamination risk. The two other eye drop recalls were not linked to the bacteria outbreak. 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. Eight people also have lost their vision and four have had their eyeballs removed, according to the Centers for Disease Control and Prevention. Why Trust Us? The FDA has determined these issues indicate a lack of sterility assurance. The deadly bacteria linked to recalled eyedrops causing infection and blindness had never been seen in the U.S. until 2022, according to the Centers for Disease Control and Prevention. Altaire has also requested that Walgreens notify its customers.Altaire has notified Walgreens by e-mail on July 3, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. They tend to be gentle on the eyes and can be used more frequently throughout the day.. But CDC officials have also indicated they are still actively investigating the source of bacterial contamination there's a possibility that more recalls may take place in the future as healthcare providers learn more about those impacted by tainted eye drops. 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. 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. The CDC and FDA urge patients to immediately stop using the recalled eye drops even if they haven't experienced an adverse reaction. CDC issued an alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA. If you have "artificial tears" eye drops in your home, check to make sure you don't have one of these recently recalled products. There have not been reports of illness or infection related to the product. What to Know About the Recent Eye Drop Recalls, https://www.nytimes.com/article/eye-drops-recall-explained.html. Best preservative-free: Systane Ultra Lubricant Eye Drops. Sign up for our newsletter to get tips directly in your inbox. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification. Brimonidine Tartrate Ophthalmic Solution, 0.15%. It was later expanded to include Delsam Pharma Artificial. 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. 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. kava and 9 other risky dietary supplements. Eyeglass temples: How do you know if they're the right length? 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. 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. To use eye drops safely, Dr. Tylka said that people should use their own bottle and make sure it has not expired. Over-the-counter medical products aren't as closely regulated as prescription drugs, noted CBS News medical contributor Dr. David Agus. To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product. 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. 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. These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile. The recall affects nearly 2,900 bottles, according to the company. Patients should not use eye-care products beyond the expiration date, as they may not be stable or sterile, Ma explained. 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. 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. Global Pharma Healthcare said in a a statementthat consumers who use the contaminated eye drops could go blind. 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,. Global Pharma recalled eye drops in February after they were tied to a drug-resistant bacteria strain linked to at least three deaths. The CDC instructs those who are experiencing such symptoms and have used either of the two eyedrops to seek medical care immediately. Angelika Warmuth/Picture-Alliance-DPA, via Associated Press, The manufacturer of EzriCare Artificial Tears said it was recalling the product out of an abundance of caution.. 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. Sign up for our newsletter to get tips directly in your inbox. The drops were manufactured in Arizona. 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. March 7, 2023 -- Two manufacturers of eyedrops have recalled products over fears about contamination and sterility. 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. Relieve. Two specific eye drop products have been expressly linked to the current Pseudomonas aeruginosa outbreak. 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. It can impair vision or even blind someone.. Turn on desktop notifications for breaking stories about interest? Apotex is recalling six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% - prescription eye drops used to treat open-angle glaucoma or ocular hypertension. 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. News provided by The Associated Press. The company said it launched the recall after finding cracks in a handful of bottle caps. 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. The products are manufactured and labeled exclusively for CVS Health. Best preservative-free eye drops: Refresh Optive Mega-3. REFRESH DIGITAL lubricant eye drops act fast to relieve eye dryness that may be due to digital device use. 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. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. The drops might be contaminated and could be a source of an outbreak of drug-resistant infections that may lead to vision loss. People who have had eye drops prescribed to them for a procedure such as cataract surgery should stop using those products once the healing process is over, she said. Since then, several additional eye products have been taken off shelves, though not all are related to the bacterial infection. What do the numbers on your eyeglass frames mean? In January, testing confirmed the Florida cases were caused by the same bacteria strain as cases in California, Connecticut and Utah. Both formulas protect tears from evaporating due to incomplete blinking from screen time. At least four eyedrop products have been recalled recently. Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. 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. NDC#: 59390-141-56 Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, NDC#: 59390-142-49 Product Size: 2 x 15 mL, Nano Tears TF Clear Emollient Lubricant Gel Drops, Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, NDC#: 59390-143-51 Product Size: 2 x 10 mL, Nano Tears XP Clear Emollient Lubricant Gel Drops, Altaire Ofloxacin 0.3% Ophthalmic Solution USP, ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF, ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF, ActivEyes Lubricant Eye Ointment Preservative Free, NDC#: 59390-189-50 Product Size: 3.5 gram. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. 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. 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, . Best for LASIK dryness: Refresh Plus Lubricant Eye Drops. REFRESH PLUS prescription and dosage sizes information for physicians and healthcare professionals. Available for Android and iOS devices. / MoneyWatch. Accutome Accu-WASHNDC# 63448-411-04 Product Size: 4 FL. 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. 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. FDA recalls 3 brands of eye drops. The agency first warned of the outbreak in January, and it has now infected at least 68 people in 16 states. 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. 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. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. No other lots are being recalled. 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. Heres what to know. As of March 14, the CDC had identified 68 patients across 16 states who had been infected infected by Pseudomonas aeruginosa. July 5, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Wal-Mart during the time period as indicated in the tables below. For any questions regarding product returns, contact GENCO at 877-674-2087 from 7 a.m. to 5 p.m. CST. Best for severe dry eye symptoms: GenTeal Lubricant Eye Gel. Preservative-free drops come in disposable single-use vials. REFRESH PLUS Lubricant Eye Drops instantly moisturizes and relieves mild symptoms of eye dryness, including burning, irritation, and discomfort. The company hasn't received any reports of injuries related to the drops. Earlier this year, there were at least two distinct recalls that were linked to potential bacterial contamination, with CDC agents indicating that EzriCare Artificial Tears were most commonly cited in the bulk of reported infections thus far. Look down and gently . February 23, 2023 --Global Pharma Healthcare is voluntarily recalling Batch No. Last week, the FDA posted a separate recall announcement from Apotex recalling six lots of prescription eyedrops used to treat a form of glaucoma. These drops are used to treat eye irritation and swelling. An Apotex spokesperson said the company has observed four bottles with cracked caps and that there have been no reports of negative health outcomes related to the product. Get browser notifications for breaking news, live events, and exclusive reporting. Pharmacology, adverse reactions, warnings and side effects. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 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. A majority of those affected reported using preservative-free EzriCare Artificial Tears before they became. Over the course of the year, other states received multiple reports of drug-resistant Pseudomonas, including a report of a Washington man who died after suffering bloodstream infection linked to over-the-counter eye drops. 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. In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. The companies involved in the recalls are Phoenix-based Pharmedica and Florida-based Apotex. No other lots are being recalled. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. 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. 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. The import alert prevents these products from entering the United States. Here's how. 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. online, by mail or by fax. First published on March 8, 2023 / 5:32 PM. Are Systane Ultra eye drops right for you. 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. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Product Description: Clear Eyes Redness Relief (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. No infections have been associated with this over-the-counter product. The F.D.A. If you think you may have an eye infection, contact your eye care provider. 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. 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. U.S. health officials are alerting consumers about two more recalls of eyedrops due to contamination risks that could lead to vision problems and serious injury. The company said that using the contaminated ointment could lead to infections that cause blindness, though it has not received any reports of injuries related to the product. All About Vision does not provide medical advice, diagnosis or treatment. Apotex "Brimonidine Tartrate Ophthalmic Solution, 0.15%." If it is truly bacterial, a direct eye exam will determine it, since there are certain clinical features we can see that would suggest bacteria and the degree of infection, Dave Patel, an ophthalmologist at the Mayo Clinic in Phoenix, told The Post. 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. Patients without symptoms do not need to undergo testing. The FDA Alerts below may be specifically about Refresh Plus or relate to a group or class of drugs which include Refresh Plus. 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. 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. 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. Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday Friday from 9 am 5 pm ET. More often than not, this particular strain of bacteria is resistant to antibiotic treatments and can especially prove deadly for those with weakened immune systems and those who are receiving care in hospital and clinic settings. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death. Pharmedica is recalling its Purely Soothing 15% MSM Drops meant to treat eye irritation.