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According to CDC materials, the bacteria Pseudomonas aeruginosa is naturally found in the world around us; usually in water, soil and human waste. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. Do Not Sell or Share My Personal Information. Patients should not use eye-care products beyond the expiration date, as they may not be stable or sterile, Ma explained. NanoTears HA PF Multi Dose Lubricant Gel Drops, Nano Tears MO Clear Emollient Mineral Oil Lipids, Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, NDC#: 59390-144-51 Product Size: 2 x 10 mL, Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose, Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free. Accutome Accu-WASHNDC# 63448-411-04 Product Size: 4 FL. TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. 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. He also urged consumers to consider whether they really need to use eye drops. 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. Why Trust Us? 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. 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. 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. Global Pharma recalled eye drops in February after they were tied to a drug-resistant bacteria strain linked to at least three deaths. 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 UC Davis Eye Center has not seen any cases linked to the EzriCare drops, but infections have been reported in 12 states, including California. 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. 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. 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. Hearst Magazine Media, Inc. All Rights Reserved. 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. As a subscriber, you have 10 gift articles to give each month. Eating like a centenarian can help you live a longer life. Eye Drops for Dry Eye Relief | Refresh Brand - Allergan 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. 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. The company hasn't received any reports of injuries related to the drops. Both formulas protect tears from evaporating due to incomplete blinking from screen time. 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. Eyeglass temples: How do you know if they're the right length? For any questions regarding product returns, contact GENCO at 877-674-2087 from 7 a.m. to 5 p.m. CST. 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. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. Apotex said in an email that the eyedrops were manufactured in Canada. With officials at the Centers for Disease Control and Prevention (CDC) issuing first warnings on the uptick in bacterial infections back in January 2023, CDC agents have now identified nearly 70 patients in 16 different states that have suffered drug-resistant infections and multiple symptoms. 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. 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. Patients without symptoms do not need to undergo testing. 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. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death. 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. Two specific eye drop products have been expressly linked to the current Pseudomonas aeruginosa outbreak. For more information about drug recalls, visit the FDA website. The products are manufactured and labeled exclusively for Wal-Mart. The products are manufactured and labeled exclusively for CVS Health. 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. Please enter valid email address to continue. 2023 CBS Interactive Inc. All Rights Reserved. Turn on desktop notifications for breaking stories about interest? Find an eyecare professional and book online in minutes! show all 21 brands Drug class: Ophthalmic lubricants and irrigations Medically reviewed by Drugs.com. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. Sign up for our newsletter to get tips directly in your inbox. 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. Relieve. "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. The C.D.C. 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. Last updated on Dec 27, 2022. 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. NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free. 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.". EzriCare and Delsam Pharma "Artificial Tears Lubricant Eye Drops." The import alert prevents these products from entering the United States. Global Pharma Healthcare said in a a statementthat consumers who use the contaminated eye drops could go blind. Oz. The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. 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. It can impair vision or even blind someone.. ET. The products are distributed at the retail level by Walgreens. The recall of Brimonidine Tartrate Ophthalmic Solution was initiated due to a manufacturing problem with the caps. Eyedrop recall 2023: Brands linked to Pseudomonas aeruginosa infection 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. Pseudomonas aeruginosa is an aggressive bacterium that is found all over the environment, including in water, soil and human waste. The frequency and color of poop can vary. There's no indication the latest recalls are related to those products. ET. The Phoenix-based company said consumers should immediately stop using the drops and return them to the place they were purchased. Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this. The product can be identified by the labels below. Delsam Pharma Artificial Tears Lubricant Eye Drops. 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. 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. Try these 6 ways to slow memory decline and lower dementia risk. . Heres what to know. Pharmedica is recalling its Purely Soothing 15% MSM Drops meant to treat eye irritation. These Recalled Eye Drops Have Been Linked To Serious Infections And One 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. If you have "artificial tears" eye drops in your home, check to make sure you don't have one of these recently recalled products. Pharmedica on Friday said it is recalling two lots of Purely Soothing 15% MSM Drops due to problems that could result in blindness." 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. 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. Anyone who has issues with any of the recalled eye drops can file a report with the F.D.A. We're recapping that information below. Over-the-counter medical products aren't as closely regulated as prescription drugs, noted CBS News medical contributor Dr. David Agus. said. Pharmedica USA LLC is advising customers to immediately stop using the product and return it to the place of purchase. Three people have died and eight patients reported vision loss, according to the agency. 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.