No other lots are being recalled. by Target Corp. Choose from contactless Same Day Delivery, Drive Up and more. SYSTANE ULTRA Lubricant Eye Drops are clinically proven to deliver high-performance dry eye symptom relief that lasts. The FDA has determined these issues indicate a lack of sterility assurance. Systane Long Lasting Lubricant Eye Drops Vials Eye Drops, 30 Count, 0.7-mL Each. 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. Available for Android and iOS devices. Audience: Consumer, Eye Care, Pharmacy, Patient, Health Professional. If you’re trying to assess which offers the best value, compare the drops based on the price per ounce. Altaire Pharmaceuticals expanded its voluntary recall of multiple eye drops and other products. Alcon will replace any purchased bottles of Systane Free Liquid Gel with a 15mL bottle of its original formulation of Systane lubricant eye drops. Eye drop recall . Alcon has distributed more than 5 million bottles of Systane Free Liquid Gel since its introduction in January 2006. Systane Balance Recall. Systane lubricant eye drops use the original formulation that made the Systane family of products the #1 doctor recommended brand for dry eye relief. 14 brands, 120 products, 619 lots affected. SYSTANE® ULTRA Lubricating Eye Drops can provide lasting relief from the symptoms of dry eye. Learn more about Systane Ultra Lubricant Eye Drops High Performance 10mL in Eye Care, Everyday Medicines & First Aid with Shoppers Drug Mart Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. If you use Systane Ultra (artificial tears eye drops) on a regular basis, use a missed dose as soon as you think about it. Retailers, distributors, customers and consumers can identify if their bottles are subject to the recall by locating the words "Free" and "Liquid Gel" on the product box or bottle. Product Title Systane Ultra Lubricant Eye Drops for Dry Eye Symptoms, 25 Preservative-Free Single Use Vials Average Rating: ( 4.8 ) out of 5 stars 57 ratings , based on 57 reviews Current Price $11.96 $ 11 . This product is distributed only in the U.S, including Puerto Rico. Preservative free formula minimizes irritation. Tara Cortes, PhD, RN, president and CEO of Lighthouse International (left), with Donald J. Alcon Laboratories has voluntarily recalled its Systane Free Liquid Gel lubricant eye drops. Shop for systane restorative eye drops online at Target. More Buying Choices $18.99 (8 … Nitrogen is an essential nutrient for the growth of microbial contaminants. 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. Altaire takes its mission of customer safety and providing quality products very seriously. This recall is in response to 11 consumer reports citing the presence of foreign material. Optimal Dry Eye ReliefFast-acting HydrationTear Evaporation ProtectionNano-droplets for Better Coverage3 Bottles, 10 ml. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. If these words are not on the bottle or box, the product is safe for use and is not subject to this recall. Eye drops sold in single-use packages are more expensive than drops that come in a single bottle. last updated 7/24/2019. We comply with the HONcode standard for trustworthy health information -, www.accessdata.fda.gov/scripts/medwatch/index.cfm. These lubricant eye drops have been clinically proven to reduce both the signs and symptoms of dry eye, quickly. No other lots are being recalled. 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. OZ. 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. Provides soothing relief from serious dry eye, including Dry Eye related to Refractive Laser Eye Surgery & Sjögren’s Syndrome. Add Recall Info. Message. each 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. Fifteen CVS Health-brand over-the-counter eye drops and ointments, 15 Ocusoft eye products and 28 … Manufacture dates range from 2016 to 2019. OTC product types include: lubricant eye drops and gels, allergy drops, redness relievers, lubricating ointments, sodium chloride ointments and solutions, and eye … Systane Long Lasting Lubricant Eyedrops / B001ET7694 I used eyedrops daily with my contacts, but after I had Lasik, I found that my old solutions stung my 'new' eyes a little and I didn't care for them as much. The original formulation of Systane is based on the Polyquad preservative system that has been used for more than 20 years to prevent contamination of eye-care products. SYSTANE ULTRA prescription and dosage sizes information for physicians and healthcare professionals. Altaire … 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. 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. Be careful not to purchase a container with more eye drops than you think you’ll use, especially if the eye drops are preservative-free. Product Description: Lubricant Eye Drops Moisturizing Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL, Product Description: Lubricant Eye Drops Moisturizing Twin PackWalgreens item #: 801477 NDC #: 0363-0185-49 Package Size: 2 x 15 mL, Product Description: Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Walgreens item #: 801482 NDC #: 0363-7500-50 Package Size: 3.5 gram, Product Description: Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL, Product Description: Lubricant Eye Ointment PF SoothingWalgreens item #: 801486 NDC #: 0363-0191-50 Package Size: 3.5 gram. Lighthouse sponsored a lecture by Dr. D'Amico and reception to welcome him to New York City, where he is a new professor and Chair of Ophthalmology at the Weill Cornell Medical Center, and ophthalmologist-in-chief at New York Presbyterian Hospital.After testing particles from the opened, partially used bottles that were returned to Alcon, the company identified the foreign material as mold. $32.97. Choose from contactless Same Day Delivery, Drive Up and more. Preservatives could begin to irritate your eyes after a while. For drops/gels, place the dropper directly over the eye and squeeze out 1 or 2 drops as needed. For the latest FDA MedWatch alerts, go here. Plus we have a $3 off Systane Eye Drops printable coupon to use on this deal that will further reduce the price Add all three to Cart Add all three to List. Systane has shown to provide soothing comfort so your eyes feel moist and refreshed longer. July 16, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold by Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige Brands Inc., during the time period as indicated in the tables below. No other lots are being recalled. Do not use. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. OTC product types include: lubricant eye drops and gels, allergy drops, redness relievers, lubricating ointments, sodium chloride ointments and solutions, and eye … The products are distributed at the retail level by CVS. Ingredients, Usage and Safety . Learn about SYSTANE® eye drops, eye care products, and important information about dry eye symptom relief. The nationwide eye drops recall continues to grow. July 10, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at CVS Health the during the time period as indicated in the tables below. 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. This voluntary recall is in response to 11 consumer reports citing the presence of foreign material. ET. Accutome Accu-WASHNDC# 63448-411-04 Product Size: 4 FL. Alcon has received no reports of fungal infections associated with the 11 reports. Preservative free formula … 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. This recall is being carried out to the retail level and is only for the specific lots listed above. No other formulations of Systane lubricant eye drops are included in the recall. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. Alcon Laboratories, a subsidiary of Alcon, is recalling only the Systane Free Liquid Gel eye drop formulation, which it distributed only in the United States and Puerto Rico. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. D'Amico, MD. Altaire ships the products labeled for Walgreens only to Walgreens. If you aren’t sure which Systane eye drops to choose, ask your optometrist for a recommendation. Two great 10 mL products in one convenient pack. Travatan Z solution does not contain any nitrogen source, such as AMP, which is present in Systane Free Liquid Gel. NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free. The company estimates that the pre-tax cost of the recall will be in the range of $8 million to $10 million. Systane ® BION TEARS ® Lubricant Eye Drops Soothing relief for serious dry eye related to Laser Eye Surgery. FORT WORTH, Texas--Alcon Laboratories, a subsidiary of Alcon (NYSE:ACL) announced a voluntary recall of Systane Free LIQUID GEL lubricant eye drops, in response to 11 consumer reports citing the presence of foreign material. Oz. It forms a smooth, protective layer for the eyes that provides long-lasting dry eye symptom relief at night. The foregoing products are manufactured and labeled by Altaire Pharmaceuticals, Inc. Altaire has notified all distributors by e-mail on July 15, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Reproduction in whole or in part without permission is prohibited. 96 … Systane Ultra Lubricant Eye Drops, Twin Pack, 10-mL Each,packaging may vary 4.8 out of 5 stars 11,358. Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday through Friday from 8:30 a.m. to 5:00 p.m. CVS Health Natural Tears Lubricant Eye Drops Preservative Free, Item#: 538397 Product Size: 0.6 mL x 32 ct, CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 495334 Product Size: 0.6 mL x 60 ct, Item#: 994883 Product Size: 0. Get it as soon as Mon, Jan 18. Systane ® ULTRA LUBRICANT EYE DROPS HIGH PERFORMANCE EXTENDED PROTECTION FAST SYMPTOM RELIEF #1 Doctor Recommended Brand 1 Alcon STERILE 10 mL (⅓ FL OZ) Systane ® LUBRICANT EYE DROPS ULTRA HIGH PERFORMING DRY EYE RELIEF Fast-acting hydration and lasting relief Moisture rich formula #1 Doctor Recommended Brand 1 Alcon STERILE 10 mL (1/3 FL 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. The products, manufactured by Altaire Pharmaceuticals, were sold under the Equate, Support Harmony and Walgreens brands from 2017 to 2019. It is also Preservative-Free. NDC#: 59390-175-35 Product Size: 4 Fl. If over-the-counter lubricating eye drops aren’t working for you, consult with your eye doctor about other possible treatment options. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. Ingredients, Usage and Safety Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. 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. TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. Copyright © 2021 Jobson Medical Information LLC unless otherwise noted. Oz. Cancel Post Message. SYSTANE ® NIGHTTIME Ointment is designed to keep your eyes lubricated and comfortable while you sleep. 00 ($28.79/Fl Oz) Save 5% more with Subscribe & Save. The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday – Friday from 9 am – 5 pm ET. 14 brands, 120 products, 619 lots affected. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Alcon has distributed over 5 million bottles of Systane Free LIQUID GEL since its introduction in January 2006. Add Info. recalls In a nutshell. 0 Reviews. Questions & Answers. Alcon's testing of returned product and retained samples from the lots with reports of mold has determined that the cause of the product problem is the specific formulation of Systane Free Liquid Gel, and is not the result of any manufacturing processes. Alcon has distributed over 5 million bottles of Systane ® Free LIQUID GEL since its introduction in January 2006. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. Oz. Do not use more often than told by the doctor. Get an alert when a recall is issued. Depending on the severity of your dry eye symptoms and your eye health needs, some Systane eye drops may be a better fit for your needs than others. 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. Systane Ultra Eye Drops Lubricant High Performance. Extended protection fast symptom relief. Ptosis or a Different Diagnosis: Asking the Right Questions Before Treatment. • 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. Altaire said it was recalling products sold at Walgreens including Lubricant Eye Drops Moisturizing, Lubricant Eye Drops Moisturizing Twin Pack, Sodium Chloride Ophthalmic Ointment 5 … The 5 million bottles of over-the-counter product have been pulled from the American market due to 11 individual consumer reports of foreign material in the bottle. This Ultra formula provides you with the extended relief that you need. If you use Systane (artificial tears eye drops) on a regular basis, use a missed dose as soon as you think about it. However, because of the characteristics of these molds, the development of an infection is considered unlikely. Altaire has also requested that Wal-Mart notify its customers. CVS: Systane Ultra Eye Drops ONLY $4.34 Each Thru 12/26. Altaire ships the products labeled for CVS only to CVS. For example, Systane Balance Lubricant Eye Drops contain propylene glycol at 0.6% as the active ingredient, while Systane Ultra Lubricant Eye Drops contain polyethylene glycol at 0.4% and propylene glycol at 0.3% concentration as the active ingredients. Systane COMPLETE Lubricant Eye Drops, 30 ml. Pharmacology, adverse reactions, warnings and side effects. The FDA has determined these issues indicate a lack of sterility assurance. Do not use 2 doses at the same time or extra doses. Therefore, the recall applies only to Systane Free Liquid Gel. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. 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. 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. 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. 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. Systane Balance Lubricant Eye Drops, Restorative Formula, Twin pack, 0.33 Fluid Ounce. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. No other formulations of Systane ® lubricant eye drops are included in this recall. Altaire has notified CVS by e-mail on July 10, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death. 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. Systane is a brand that offers lubricating eye drops to help relieve dry eye. No other formulations of Systane ® lubricant eye drops are included in this recall. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets. The products are manufactured and labeled exclusively for Wal-Mart. The company's glaucoma drug, Travatan Z, uses an ionic buffered preservative system, sofZia, that is an extension of Alcon's borate/polyol preservative systems. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. The original formulation of Systane lubricant eye drops and Systane unit dose are not part of this recall and can continue to be used safely. Altaire has also requested that the labelers each perform a subrecall. last updated 7/24/2019. Stop using the drops if you experience itching or swelling. Consult your eye doctor. My doctor recommended Systane, and I use them in the mornings to moisten my eyes … Learn more about eye health including changes with aging eyes, living with dry eye, dry eye symptoms and causes. Sears has the best selection of Systane Eye Drops in stock. No other formulations of Systane lubricant eye drops are included in this recall. Learn more at systane.com. 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. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. Systane Ultra Lubricant Eye Drops may be used to lubricate and re-wet daily, extended wear and disposable silicone hydrogel and soft (hydrophilic) contact lenses. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The products are manufactured and labeled exclusively for CVS Health. TO DATE, ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATION RESULTS, INCLUDING IN-HOUSE AND THIRD-PARTY STERILITY TESTING, FOR THESE PRODUCTS. Get Coupons . A Retail Level recall is limited to product lots currently in inventory at the chain store. 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. 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. No other lots are being recalled. The 5 million bottles of over-the-counter product have been pulled from the American market due to 11 individual consumer reports of foreign material in the bottle. Select one or more newsletters to continue. Cataract/Glaucoma Surgeons Suffer CyPASS Withdrawal, Study: Differences in Stability Between Tecnis and Acrysof, AMD Patients Recover Vision After Stem Cell Treatment. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. This voluntary recall is in response to 11 consumer reports citing the presence of foreign material. Available in 15 and 30mL bottles, Systane offers the relief you need to get you through your day. For information, call 1 (866) 608-3936 or visit www.systane.com. July 8, 2019 -- Altaire Pharmaceuticals has recalled a wide variety of over-the-counter eyedrop solutions, ointments, and other products sold at Walmart and Walgreens. Ask a Question/Reply. 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.). Side Effects & Adverse Reactions. Ask a Question. NDC#: 59390-175-18 Product Size: 1 Fl. The products are manufactured and labeled exclusively for Walgreens. Eye Drops & Products for the Treatment and Relief of Dry Eye Symptoms . All rights reserved. The product is distributed only in the … Eye Gel Drops Systane was recommended by my Opthalmologist and I will continue using Systane as they seem to be doing the job. 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. Its voluntary recall is in response to 11 consumer reports citing the presence of foreign.! Do not use 2 doses at the same time or extra systane eye drops recall tears... To DATE altaire has also recalled a variety of products sold by CVS approvals, alerts warnings. Eyes lubricated and comfortable while you sleep safely by consumers since 2003, Laboratories! Or 2 minutes infections or death such as AMP, which is present in Free... 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