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 product can be identified by the photos provided below. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. In March, a woman in Florida sued Global Pharma, claiming that an infection caused by the eye drops was so severe that doctors had to surgically remove one of her eyes. 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. ET. No other lots are being recalled. Bacteria in recalled eye drops linked to cases of vision loss - CNN Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 oz. Updated on: March 24, 2023 / 10:49 AM This over-the-counter product is being recalled due to non-sterility. Accutome Accu-WASHNDC# 63448-411-04 Product Size: 4 FL. 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. 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. Pharmedica recalled two lots of Purely Soothing 15 percent MSM Drops because they were not sterile. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. 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. 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. REFRESH PLUS is preservative-free which means it's great for sensitive eyes and can be used after LASIK or other eye surgeries. More than five eye drop brands have launched recalls while health officials investigate a serious bacterial outbreak linked to blindness, eye loss and three deaths. TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. 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. 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. kava and 9 other risky dietary supplements. Pharmedica is recalling its Purely Soothing 15% MSM Drops meant to treat eye irritation. The FDA has determined these issues indicate a lack of sterility assurance. We're recapping that information below. 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. Eye drop recall 2023: The full list of brands that have been recalled - MSN 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. Refresh Uses, Side Effects & Warnings - Drugs.com Clear Eyes Redness Relief (Little Drug) , Product Size: 0.2 oz. Eye drops can cause infections in other parts of the body because the eye connects to the nasal cavitythrough the tear ductsand germs can move from the nasal cavity into the lungs. requires a company to keep back. 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.. 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. 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. For drops/gels, place the dropper directly over the eye and squeeze out 1 or 2 drops as needed. Another manufacturer,Apotex, on March 1 recalled six lots of its own brand of glaucoma drops, called "Brimonidine Tartrate Ophthalmic Solution, 0.15%," which is for patients with open-angle glaucoma or ocular hypertension. said. Delsam Pharmas Artificial Eye Ointment, which has not been linked directly to illness but was produced by Global Pharma Healthcare, the same manufacturer behind the Delsam Pharmas artificial tears, has also been recalled. March 3, 2023 -- Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. online, by mail or by fax. 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. The maker of eye drops for dry eye, rewetting drops and eye ointments sold at CVS, Walgreens and Walmart cited concerns about sterility of the ophthalmic products made at its manufacturing facility, according to the Food and Drug Administration. 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.). They include EzriCare and Delsam Pharmas Artificial Tears, which have been associated with the bacterial infection. Purely Soothing, 15% MSM Drops were recalled due to non-sterility. REFRESH PLUS Dosage & Rx Info | Uses, Side Effects - MPR 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. Eye Drops Recall 2023: List of Brands Linked to Potential Infections "Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating whether contamination may have occurred during manufacturing," per current CDC reports. 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. The company hasn't received any reports of injuries related to the drops. On March 1, Apotex recalled prescription eye drops used to reduce eye pressure in people with glaucoma or ocular hypertension. Allergan recalls Refresh, FML, Blephamide eye drops A Full List of Recalled Eye Drops Linked to Potential Bacterial - Yahoo 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. Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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 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. To use eye drops safely, Dr. Tylka said that people should use their own bottle and make sure it has not expired. 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. EzriCare and Delsam Pharma "Artificial Tears Lubricant Eye Drops." WASHINGTON -- 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.