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. "Patients reported over 10 different brands of artificial tears and some patients used multiple brands," the CDC indicated. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. UC Davis Health experts share what you need to know. Original strength, preseravtive-free formula acts like your own natural tears and comes in sterile, single-use vials you can take with you anywhere. As of March 14, the CDC had identified 68 patients across 16 states who had been infected infected by Pseudomonas aeruginosa. The over-the-counter drops are designed to treat eye irritation. The companies involved in the recalls are Phoenix-based Pharmedica and Florida-based Apotex. First published on March 8, 2023 / 5:32 PM. Eyeglass temples: How do you know if they're the right length? The FDA has determined these issues indicate a lack of sterility assurance. Updated on: March 24, 2023 / 10:49 AM Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax. The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. The bacterium is resistant to most antibiotics and is particularly dangerous in health-care settings and for people with weakened immune systems. The F.D.A. The product can be identified by the labels below. TRP/TARGET up & up intensive relief lubricating eye drops, Product Size: 10 mL, TRP Pink Eye Relief , Product Size: 10 mL, Lubricant Eye Drops Moisturizing, Package Size: 15 mL, Lubricant Eye Drops Moisturizing Twin Pack, Package Size: 2 x 15 mL, Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment, Package Size: 3.5 gram, Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, Package Size: 15 mL, Lubricant Eye Ointment PF Soothing, Package Size: 3.5 gram, Equate Restore Tears Lubricant Eye Drops Twin Pack, Package Size: 2 x 15 mL, Equate Eye Allergy Relief Drops, Package Size: 15 mL, Equate Sterile Lubricant Stye Ointment, Package Size: 3.5 gram, Equate Comfort Gel Lubricant Eye Gel Twin Pack, Package Size: 2 x 15 mL, Equate Restore PM Nighttime Lubricant Eye Ointment, Package Size: 3.5 gram, Equate Night & Day Restore Tears Lubricant Eye Pack, Package Size: 3.5g and 15mL, Equate Support Advanced Twin Pack, Package Size: 2 x 15 mL, Equate Support Advanced Lubricating Eye Drops Dose Preservative Free, Package Size: 25 count (0.6 mL fill), Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, Package Size: 7.5 mL, Equate Support Moisture Lubricant Eye Drops, Package Size:10 mL, Support Harmony Lubricant Eye Drops, Package Size: 10 mL (Note: Support Harmony packaging was discontinued in January 2018.). 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. has also warned people to stop using an eye ointment manufactured by Global Pharma because of possible contamination. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. The recall affects nearly 2,900 bottles, according to the company. Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. Purely Soothing, 15% MSM Drops were recalled due to non-sterility. Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.) Apotex "Brimonidine Tartrate Ophthalmic Solution, 0.15%." The announcements follow a recall last month of eyedrops made in India that were linked to an outbreak of drug-resistant infections. The products are distributed at the retail level by Wal-Mart. 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. Delsam Pharma Artificial Tears Lubricant Eye Drops. current good manufacturing practice (CGMP), www.accessdata.fda.gov/scripts/medwatch/index.cfm. Best for extended relief: Blink Tears Lubricating Eye Drops. 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. Weeks later, two other types of eye drops were recalled because they posed a different kind of contamination risk. This over-the-counter product is being recalled due to non-sterility. 24/7 coverage of breaking news and live events. 1-2 drops in affected eye(s . The people who were sickened most commonly reported using EzriCare brand eye drops, while some patients used multiple brands. More eye drops are being recalled. Apotex recalled six lots of Brimonidine Tartrate Ophthalmic Solution 0.15 percent prescription eye drops. Oz. Sign up for the Well+Being newsletter, your source of expert advice and simple tips to help you live well every day. 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. An additional four have had to have their eyeballs surgically removed to prevent further side effects or more serious symptoms. Dr. Starr and Dr. Tylka both emphasized that, while the recalls were worrying, eye drops are generally safe. Clear Eyes Once Daily, Eye Allergy . To safely apply eye drops, she said, people should use their nondominant hand to gently tug on the lower eyelid, look up slightly, and then, with the dominant hand, put that little drop in that lower cul-de-sac in the eyelid area.. Best for LASIK dryness: Refresh Plus Lubricant Eye Drops. 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. 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. Clear Eyes Redness Relief (Little Drug) , Product Size: 0.2 oz. Clear Eyes Redness Relief (Select Corp) , Product Size: 0.2 oz. 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. The Eye Center team aims to transform vision care and develop cures for blinding eye diseases, from cornea to cortex. ET. Powered and implemented by FactSet. 2023 CBS Interactive Inc. All Rights Reserved. Pharmedica USA in March recalled Purely Soothing, 15% MSM Drops out of concern that the product is not sterile. Teva Pharmaceuticals have set up a recall hotline at 888-838-2872 for shoppers who have additional questions. As of March 14, 68 patients across 16 states were found to have contracted the bacteria, known as Pseudomonas aeruginosa. 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. 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. The drops have not been linked to illness, the company said, though it cautioned. Select one or more newsletters to continue. Reboot. No other lots are being recalled. "If we don't really need something, then we probably shouldn't be using it. 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. The CDC and FDA urge patients to immediately stop using the recalled eye drops even if they haven't experienced an adverse reaction. Legal Statement. On March 3, Pharmedica recalled two lots of Purely Soothing 15 percent MSM. 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. 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.. Two brands of eye drops have been pulled from shelves in January and February after they were linked to a drug-resistant bacteria strain that has caused at least three deaths and serious health issues in several others. At least four eyedrop products have been recalled recently. 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. To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product. Altaire ships the products labeled for CVS only to CVS. No infections have been associated with this over-the-counter product. 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. Product Description: Clear Eyes Redness Relief (Select Corp)UPC#: 6-55708-01039-6 Product Size: 0.2 FL. Turn on desktop notifications for breaking stories about interest? Millions of consumers use nonprescription, over-the-counter drops daily as a remedy for dryness, irritation and other mild eye conditions. show all 21 brands Drug class: Ophthalmic lubricants and irrigations Medically reviewed by Drugs.com. NDC#: 59390-175-35 Product Size: 4 Fl. Here are three ways to improve sleep. He notes that patients should pay attention to recalls like those announced by the FDA, but they dont need to stop using all eye drops, which are safe when used correctly. 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. Change in eyesight, eye pain, or very bad eye irritation. by Target Corp. In January, testing confirmed the Florida cases were caused by the same bacteria strain as cases in California, Connecticut and Utah. 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. 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. 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. 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. Eight people also have lost their vision and four have had their eyeballs removed, according to the Centers for Disease Control and Prevention. Pharmedica is recalling its Purely Soothing 15% MSM Drops meant to treat eye irritation. 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.
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