All About Vision does not provide medical advice, diagnosis or treatment. Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. Here's how. Are Systane Ultra eye drops right for you. 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. These drops are used to treat eye irritation and swelling. The agency first warned of the outbreak in January, and it has now infected at least 68 people in 16 states. Patients who have previously used potentially unsafe products should contact their doctors and ask for a safe substitute. 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. 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. The company hasn't received any reports of injuries related to the drops. An Apotex vice president, Jordan Berman, said in an email that the company had seen only four bottles with cracked caps. Altaire has notified Wal-Mart 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. Altaire Pharmaceuticals issued voluntary recalls for eye drops and ointments sold at CVS, Walgreens, Walmart and through Perrigo and others. 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. 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. No infections have been associated with this over-the-counter product. Additional eye drop recalls are making headlines this month, but it's important to note that they are not expressly related to bacterial infections being linked to Pseudomonas aeruginosa. Anyone can read what you share. The products are distributed at the retail level by Wal-Mart. "Ask your eye doctor whether you really need them," Agus said. The content on this site is for informational purposes only. Which Eye Drops Are Being Recalled? Try these 6 ways to slow memory decline and lower dementia risk. 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. 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. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification. And symptoms triggered by this particular bacterial infection may start presenting usually within 12 to 24 hours, per published research. 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. ET. March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. 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. Over-the-counter medical products aren't as closely regulated as prescription drugs, noted CBS News medical contributor Dr. David Agus. The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. 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. A Retail Level recall is limited to product lots currently in inventory at the chain store. Infections can present in ways such as keratitis, sepsis and respiratory and urinary tract infections. Oz. 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. 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 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Original strength, preseravtive-free formula acts like your own natural tears and comes in sterile, single-use vials you can take with you anywhere. 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. 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. The products are distributed at the retail level by the labelers identified herein. The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles. It has . Anyone experiencing symptoms and who have used either of the two branded eye drops recently should seek immediate emergency medical care. The products are manufactured and labeled exclusively for Wal-Mart. 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. 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. EzriCare and Delsam Pharma "Artificial Tears Lubricant Eye Drops." The CDC and FDA urge patients to immediately stop using the recalled eye drops even if they haven't experienced an adverse reaction. To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product. An additional four have had to have their eyeballs surgically removed to prevent further side effects or more serious symptoms. Why it matters: The recall notices for select lots of Purely Soothing 15% MSM Drops and Brimonidine Tartrate Ophthalmic Solution did not list any illnesses or injuries from the products but "using . Health officials said the outbreak is linked to using artificial tears. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Brimonidine Tartrate Ophthalmic Solution, 0.15%. Dr. Starr and Dr. Tylka both emphasized that, while the recalls were worrying, eye drops are generally safe. 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. 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 drops were manufactured in Arizona. Best for LASIK dryness: Refresh Plus Lubricant Eye Drops. requires a company to keep back in case issues like these arise. Read on to learn which eye drops are being recalled and why. 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. 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. 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. No other lots are being recalled. This product is being recalled due to non-sterility. 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. Best for severe dry eye symptoms: GenTeal Lubricant Eye Gel. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. FDA recommended this recall due to the companys current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging. At the time of the recall, there were 55 reports of adverse reactions to the drops, including eye infections, permanent vision loss and one death from a bloodstream infection. To use eye drops safely, Dr. Tylka said that people should use their own bottle and make sure it has not expired. Global Pharma Healthcare said in a a statementthat consumers who use the contaminated eye drops could go blind. Find an eyecare professional and book online in minutes! REFRESH PLUS Lubricant Eye Drops instantly moisturizes and relieves mild symptoms of eye dryness, including burning, irritation, and discomfort. There have not been reports of illness or infection related to the product. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. Altaire takes its mission of customer safety and providing quality products very seriously. 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. See the complete list. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. Altaire ships the products labeled for CVS only to CVS. .css-lwn4i5{display:block;font-family:Neutra,Helvetica,Arial,Sans-serif;font-weight:bold;letter-spacing:-0.01rem;margin-bottom:0;margin-top:0;text-align:center;-webkit-text-decoration:none;text-decoration:none;}@media (any-hover: hover){.css-lwn4i5:hover{color:link-hover;}}@media(max-width: 48rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}@media(min-width: 40.625rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}@media(min-width: 48rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}@media(min-width: 64rem){.css-lwn4i5{font-size:1.375rem;line-height:1.1;}}8 Surprising Benefits of Cycling, 12 Potential Arcturus COVID Symptoms to Know, The Reason Why You Buy Things When You're Drunk, Heres the Real Reason Why You Get Toe Cramps, How Buccal Fat Removal Surgery Actually Works. The voluntary recall has since expanded to include over-the-counter and prescription eye care products sold under the Altaire brand name and products labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc., Natural Ophthalmics, OCuSOFT, Prestige and TRP Co. Altair reports that to date it has not received any reports of adverse effects from the voluntarily recalled products, nor has Altaire found any out-of-specifications outcomes of sterility testing for the products. The two lots . 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. These are over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile. Patients should not use eye-care products beyond the expiration date, as they may not be stable or sterile, Ma explained. The people who were sickened most commonly reported using EzriCare brand eye drops, while some patients used multiple brands. Historically, it has caused infections through sepsis (in the blood) or respiratory and urinary tract infections, with upwards of 33,000 recorded cases in the same year. He has written about food and dining for Time, among other publications. Additionally, some product packaging is leaking or may otherwise be compromised. Pharmedica is recalling its Purely Soothing 15% MSM Drops meant to treat eye irritation. First published on March 8, 2023 / 5:32 PM. CBS News' Alexander Tin and the Associated Press contributed to this report. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Sign up for our newsletter to get tips directly in your inbox. 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. 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.". 1-2 drops in affected eye(s . 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. Get browser notifications for breaking news, live events, and exclusive reporting. There are a few other eye drops and one other eye ointment that have been concurrently recalled in the same period as the two products above but not due to the same potential bacterial exposure. What are the symptoms of eye infection to watch out for? The bacterium is resistant to most antibiotics and is particularly dangerous in health-care settings and for people with weakened immune systems. 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. Delsam Pharmas NDC for this product is 72570-122-35, and its UPC code is 3 72570 012235 3. Product Description: Clear Eyes Redness Relief (Select Corp)UPC#: 6-55708-01039-6 Product Size: 0.2 FL. Global Pharma Healthcare on February 2recalled all lots of its EzriCare and Delsam Pharma brands of "Artificial Tears Lubricant Eye Drops," which it said could be contaminated with bacteria. Pharmedica "Purely Soothing, 15% MSM Drops." 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. Dry eye disease is one of the most common eye diseases and can cause irritation, grittiness, redness, burning, tearing and blurred vision. Artificial tears can help with these symptoms, Ma explained. The affected product is packaged in a white aluminum tube within a paper carton. Best preservative-free eye drops: Refresh Optive Mega-3. 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. The import alert prevents these products from entering the United States. Do Not Sell or Share My Personal Information. Contact an eye doctor if you need medical attention. July 3, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Walgreens during the time period as indicated in the tables below. by Target Corp. 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. As a subscriber, you have 10 gift articles to give each month. NDC#: 59390-175-18 Product Size: 1 Fl. The Phoenix-based company said consumers should immediately stop using the drops and return them to the place they were purchased. 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 Eye Center team aims to transform vision care and develop cures for blinding eye diseases, from cornea to cortex. Other steps to prevent eye infections include making sure to wash your hands before touching your eyes or eye drops. What to Know About the Recent Eye Drop Recalls, https://www.nytimes.com/article/eye-drops-recall-explained.html. 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. We comply with the HONcode standard for trustworthy health information. "If we don't really need something, then we probably shouldn't be using it. In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. requires a company to keep back. For more information about drug recalls, visit the FDA website. Here are three ways to improve sleep. Most Facebook users can now claim settlement money. It was later expanded to include Delsam Pharma Artificial. 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. 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. Apotex said that people who received its recalled eye drops, which were distributed between April 5, 2022, and Feb. 22, should contact their health care provider and pharmacy. July 15, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the over the counter (OTC) and prescription (Rx) drug products and lots, within expiry, it has manufactured and distributed under the Altaire label and trade dress during the time period as indicated below. The CDC instructs those who are experiencing such symptoms and have used either of the two eyedrops to seek medical care immediately. FDA recalls 3 brands of eye drops. Best for nighttime relief . 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, . ICE Limitations. Shop Plus Lubricant Eye Drops - Value Size and read reviews at Walgreens. People who have used these artificial tears and who have symptoms of an eye infection should see a doctor immediately, the C.D.C. The outbreak has also been connected to eight recent reports of vision loss and four reports of enucleation, or surgical removal of an eyeball. 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. Product was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. Available for Android and iOS devices. In January, testing confirmed the Florida cases were caused by the same bacteria strain as cases in California, Connecticut and Utah. 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. 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. Legal Statement. The FDA has determined these issues indicate a lack of sterility assurance. The drops were manufactured in Arizona. The eyedrop-related strain of Pseudomonas aeruginosa has not previously appeared in the United States, the CDC said. The C.D.C. EzriCare Artificial Tears Lubricant Eye Drop. Altaire has also requested that the labelers each perform a subrecall. 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. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. 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. Its also important to check the expiration date. 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 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. Altaire takes its mission of customer safety and providing quality products very seriously. Clear Eyes Once Daily, Eye Allergy . Uses Before taking Warnings equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) - Distributed by Wal-Mart Stores, Inc. Lubricant EYE DROPS FOR MILD TO MODERATE DRY EYE, STERILE, 1 FL OZ (30 mL), for Mild to Moderate Dry Eye - Distributed by CVS Pharmacy, Inc. lubricant eye drops for mild to moderate dry eye, STERILE, 1 FL OZ (30 mL) - Dist. 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. Altaire ships the products labeled for Wal-Mart only to Wal-Mart. 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.
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