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. 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. More eye drops are being recalled. 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. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products. Product Description: Clear Eyes Redness Relief (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. 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. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. 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. Clear Eyes Redness Relief (Little Drug) , Product Size: 0.2 oz. The company did not specify how many bottles were affected or how the bottles became not sterile. Purely Soothing, 15% MSM Drops were recalled due to non-sterility. Other steps to prevent eye infections include making sure to wash your hands before touching your eyes or eye drops. February 23, 2023 --Global Pharma Healthcare is voluntarily recalling Batch No. Pharmaceutical firmPharmedica USA on Marchrecalled two lots of "Purely Soothing, 15% MSM Drops," also over sterility concerns. ET. 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. The drops were manufactured in Arizona. The eye drops could be contaminated, according to the recall, and may be associated with the CDC's ongoing investigation into "extensively drug-resistant" infections that weren't responsive. online, by mail or by fax. 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. As of March 14, 68 patients across 16 states were found to have contracted the bacteria, known as Pseudomonas aeruginosa. 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. To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product. The product can be identified by the photos provided below. Pseudomonas aeruginosa is an aggressive bacterium that is found all over the environment, including in water, soil and human waste. 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. Anyone experiencing symptoms and who have used either of the two branded eye drops recently should seek immediate emergency medical care. 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. It was later expanded to include Delsam Pharma Artificial. 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. Try these 6 ways to slow memory decline and lower dementia risk. 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. 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. The Eye Center team aims to transform vision care and develop cures for blinding eye diseases, from cornea to cortex. The company said it launched the recall after finding cracks in a handful of bottle caps. The products are manufactured and labeled exclusively for Wal-Mart. 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. Apotex is recalling six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% - prescription eye drops used to treat open-angle glaucoma or ocular hypertension. Best for nighttime relief . NDC#: 59390-175-35 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. 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. 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. 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. 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. 24/7 coverage of breaking news and live events. 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. No other lots are being recalled. What do the numbers on your eyeglass frames mean? The manufacturer, Global Pharma Healthcare, has issued a nationwide recall of the product. And symptoms triggered by this particular bacterial infection may start presenting usually within 12 to 24 hours, per published research. Two specific eye drop products have been expressly linked to the current Pseudomonas aeruginosa outbreak. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. requires a company to keep back. See the complete list. About 117 million Americans used eye drops and eyewash in 2020, according to Statista, a market research firm. 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. Which Eye Drops Are Being Recalled? CDC issued an alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA. Select one or more newsletters to continue. 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. Here's what you should know. Patients should not use eye-care products beyond the expiration date, as they may not be stable or sterile, Ma explained. 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. Dry eye disease is one of the most common eye diseases and can cause irritation, grittiness, redness, burning, tearing and blurred vision. He also urged consumers to consider whether they really need to use eye drops. requires a company to keep back in case issues like these arise. ET. 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. "Patients reported over 10 different brands of artificial tears and some patients used multiple brands," the CDC indicated. Preservative-free drops come in disposable single-use vials. Best preservative-free eye drops: Refresh Optive Mega-3. TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Altaire has also requested that Wal-Mart notify its customers. Market data provided by ICE Data Services. Novack is a clinical pharmacologist with decades of experience in ophthalmic product development. 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. 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. On January 20, the CDC told doctors to avoid recommending the EzriCare product. Read on to learn more about a current list of recalled eye drops and symptoms of bacterial eye infections to consider. The import alert prevents these products from entering the United States. Weeks later, two other types of eye drops were recalled because they posed a different kind of contamination risk. 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. David Chen, an ophthalmologist at Singapores National University Hospital, said in an email that he does not believe people should worry about other brands that have not been recalled. Consumers are advised to stop using the following brands and return them to the place of purchase. 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. At least four eyedrop products have been recalled recently. Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. If youve used Ezricare and Delsam Pharmas Artificial Tears, look out for symptoms including yellow, green or clear discharge from the eye; eye pain or discomfort; redness of the eye or eyelid; a sensation that there is something in your eye; increased sensitivity to light; and blurry vision, according to the CDC. Global Pharma on February 24 alsorecalledone batch of a product distributed by Delsam Pharma,"Artificial Eye Ointment," again due to possible microbial contamination. 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. 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. Updated on: March 24, 2023 / 10:49 AM Delsam Pharmas NDC for this product is 72570-122-35, and its UPC code is 3 72570 012235 3. The Apotex Brimonidine Tartrate notice is here and the Pharmedica Purely Soothing notice is here. Get browser notifications for breaking news, live events, and exclusive reporting. The outbreak has also been connected to eight recent reports of vision loss and four reports of enucleation, or surgical removal of an eyeball. Oz. 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. Most Facebook users can now claim settlement money. The company hasn't received any reports of injuries related to the drops. Product Description: Clear Eyes Redness Relief (Select Corp)UPC#: 6-55708-01039-6 Product Size: 0.2 FL. Both companies said the recalls were conducted in consultation with the FDA. Dr. Starr, an associate professor of ophthalmology at Weill Cornell Medicine, said that one thing some patients do wrong is press the bottle tip into the inner corner of the eye, which can contaminate the drops and scratch the surface of the eye. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. 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. REFRESH PLUS Lubricant Eye Drops instantly moisturizes and relieves mild symptoms of eye dryness, including burning, irritation, and discomfort. Amazon Marketplace, Etc.). 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. Altaire takes its mission of customer safety and providing quality products very seriously. Reboot. All About Vision and AllAboutVision.com are registered trademarks of AAV Media, LLC. The products are manufactured and labeled exclusively for CVS Health. 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. As of March 14, the CDC had identified 68 patients across 16 states who had been infected infected by Pseudomonas aeruginosa.
Pros And Cons Of Living In The Arctic,
Acreage For Sale New Brunswick,
Appalachian Living Conditions 2019,
Articles R
