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. Altaire Pharmaceuticals expanded its voluntary recall of multiple eye drops and other products. July 5, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Wal-Mart during the time period as indicated in the tables below. 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. 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. Consult your eye doctor. Two great 10 mL products in one convenient pack. Many times Systane Ultra (artificial tears eye drops) is used on an as needed basis. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. Altaire ships the products labeled for Wal-Mart only to Wal-Mart. Choose from contactless Same Day Delivery, Drive Up and more. ET. Manufacture dates range from 2016 to 2019. Many times Systane (artificial tears eye drops) is used on an as needed basis. The FDA has determined these issues indicate a lack of sterility assurance. Systane eye drops ingredients may vary based on the specific product. Nitrogen is an essential nutrient for the growth of microbial contaminants. FREE Shipping on orders over $25 shipped by Amazon. 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 products are manufactured and labeled exclusively for Walgreens. Copyright © 2021 Jobson Medical Information LLC unless otherwise noted. SofZia preservative system meets the standards of preservative effectiveness required by the United States Pharmacopoeia. Systane lubricant eye drops use the original formulation that made the Systane family of products the #1 doctor recommended brand for dry eye relief. As a precautionary measure, Altaire is voluntarily initiating this recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. OTC product types include: lubricant eye drops and gels, allergy drops, redness relievers, lubricating ointments, sodium chloride ointments and solutions, and eye … Other Systane formulations are not affected, and no ocular infections due to the recalled product have been reported. recalls In a nutshell. Add all three to Cart Add all three to List. Oz. This product is distributed only in the U.S, including Puerto Rico. 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. 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. Optimal Dry Eye ReliefFast-acting HydrationTear Evaporation ProtectionNano-droplets for Better Coverage3 Bottles, 10 ml. SYSTANE ULTRA Lubricant Eye Drops are clinically proven to deliver high-performance dry eye symptom relief that lasts. No other lots are being recalled. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Systane Ultra Lubricant Eye Drops are clinically proven to deliver extended protection and high-performance relief from your dry eye symptoms. Plus we have a $3 off Systane Eye Drops printable coupon to use on this deal that will further reduce the price 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 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. 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. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. NEW SYSTANE ® Lubricant Eye Drops HYDRATION PF PRESERVATIVE-FREE DRY EYE SYMPTOM RELIEF Convenient Single Vials On-the-Go Extra moisturizing for sensitive eyes Longer lasting hydration* #1 Doctor Recommended Brand 1 Hydro Boost Technology STERILE 30 Vials 0.7 mL (0.02 FL OZ) Alcon Experience preservative-free relief that’s extra moisturizing for sensitive eyes Common Dry Eye … Systane COMPLETE Lubricant Eye Drops, 30 ml. It has also recalled a variety of products sold by CVS. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Oz. Eye Drops & Products for the Treatment and Relief of Dry Eye Symptoms . To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including Sterility testing, for the products. 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. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. 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. However, because of the characteristics of these molds, the development of an infection is considered unlikely. Add Info. Audience: Consumer, Eye Care, Pharmacy, Patient, Health Professional. OZ. Get the Systane Eye Drops you want from the brands you love today at Sears. 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. TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. #1 doctor recommended brand New (20) from $25.60 + FREE Shipping. 4.8 out of 5 stars 1,952. These items are shipped from and sold by different sellers. Shop for systane gel drops online at Target. 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. The products are manufactured and labeled exclusively for CVS Health. Available in 3.5 g tubes. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. No other formulations of Systane lubricant eye drops are included in this recall. 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 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. Travatan Z solution does not contain any nitrogen source, such as AMP, which is present in Systane Free Liquid Gel. All rights reserved. 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) 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. Altaire … TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. Preservative free formula minimizes irritation. For information, call 1 (866) 608-3936 or visit www.systane.com. Fifteen CVS Health-brand over-the-counter eye drops and ointments, 15 Ocusoft eye products and 28 … Accutome Accu-WASHNDC# 63448-411-04 Product Size: 4 FL. Sears has the best selection of Systane Eye Drops in stock. Extended protection fast symptom relief. Find a great collection of Eyes Systane Eye Care at Costco. 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. The FDA has determined these issues indicate a lack of sterility assurance. 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. TO DATE, ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATION RESULTS, INCLUDING IN-HOUSE AND THIRD-PARTY STERILITY TESTING, FOR THESE PRODUCTS. Provides soothing relief from serious dry eye, including Dry Eye related to Refractive Laser Eye Surgery & Sjögren’s Syndrome. 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. The products are manufactured and labeled exclusively for Wal-Mart. For external use only. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Do not use 2 doses at the same time or extra doses. A Retail Level recall is limited to product lots currently in inventory at the chain store. No other lots are being recalled. Systane has shown to provide soothing comfort so your eyes feel moist and refreshed longer. Some eye drops and ointments sold over-the-counter at major retailers are being recalled due to fears that they may not be sterile. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Find the SYSTANE® product that is right for you at systane.com. Systane ® BION TEARS ® Lubricant Eye Drops Soothing relief for serious dry eye related to Laser Eye Surgery. 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. Ingredients, Usage and Safety . Systane Ultra Lubricant Eye Drops, Twin Pack, 10-mL Each,packaging may vary 4.8 out of 5 stars 11,358. Alcon has distributed more than 5 million bottles of Systane Free Liquid Gel since its introduction in January 2006. 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. 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. Alcon Laboratories has voluntarily recalled its Systane Free Liquid Gel lubricant eye drops. The products are distributed at the retail level by Walgreens. Side Effects & Adverse Reactions. Oz. Stop using the drops if you experience itching or swelling. If you’re trying to assess which offers the best value, compare the drops based on the price per ounce. Altaire takes its mission of customer safety and providing quality products very seriously. FreshKote Lubricant Eye DropsNDC# 15821-101-15 Product Size: 15 mL, Grandall Colirio Ojo De Aguila Eye DropsProduct Size: 15 mL, Grandall Colirio Oftal-Mycin Redness Relief Eye DropsProduct Size: 15mL, Product Description: Grandall Oftal-Mycin Ophthalmic OintmentProduct Size: 3.5 g, Clear Eyes Redness ReliefUPC#: 6-78112-25415-6 Product Size: 15 mL, Product Description: Clear Eyes Redness ReliefUPC#: 6-78112-25419-4 Product Size: 30 mL. Do not use. Systane Ultra Lubricating Eye Drops moisten your contact lens, reduce discomfort with contact lens wear and help to remove particulate material that may cause irritation and/or discomfort. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. We comply with the HONcode standard for trustworthy health information -, www.accessdata.fda.gov/scripts/medwatch/index.cfm. Message. Altaire ships the products labeled for CVS only to CVS. 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 … Due to complaints of mold found in the 30 mL bottles after use, concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall. More Buying Choices $18.99 (8 … BALTIMORE (WJZ) — A number of eye drops and opthalmic ointments sold at Walgreens and Walmart stores are being recalled over concerns they may not be sterile. Some eye drops and ointments sold over-the-counter at major retailers are being recalled due to fears that they may not be sterile. In stock on January 21, 2021. CVS: Systane Ultra Eye Drops ONLY $4.34 Each Thru 12/26. Product Description: Clear Eyes Redness Relief (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. 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. Preservatives could begin to irritate your eyes after a while. If you have any questions about Systane Balance (artificial tears eye drops), please talk with your doctor, nurse, pharmacist, or other health care provider. last updated 7/24/2019. SYSTANE ULTRA prescription and dosage sizes information for physicians and healthcare professionals. Altaire has notified Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige by e-mail on July 16, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots. Great deal on Systane Ultra Eye Drops at CVS. Ingredients, Usage and Safety 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. 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. Opt for preservative-free eye drops if you use them frequently. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death. Learn more about eye health including changes with aging eyes, living with dry eye, dry eye symptoms and causes. 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. Ptosis or a Different Diagnosis: Asking the Right Questions Before Treatment. Preservative free formula … 00 ($28.79/Fl Oz) Save 5% more with Subscribe & Save. Questions & Answers. Oz. Altaire is recalling 74 lots from Walmart, which include 10 Equate products and one eye drop under the Support Harmony brand, which was discontinued in January 2018, according to the recall … Show details. Learn more about Systane Ultra Lubricant Eye Drops High Performance 10mL in Eye Care, Everyday Medicines & First Aid with Shoppers Drug Mart No other lots are being recalled. recalls In a nutshell. Choose from contactless Same Day Delivery, Drive Up and more. 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. My doctor recommended Systane, and I use them in the mornings to moisten my eyes … • 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. Systane Free Liquid Gel utilizes a combination of ingredients for antimicrobial activity, including borate, aminomethylpropanol (AMP), sorbitol and zinc that together contribute to the overall preservative system. Altaire ships the products labeled for Walgreens only to Walgreens. Cataract/Glaucoma Surgeons Suffer CyPASS Withdrawal, Study: Differences in Stability Between Tecnis and Acrysof, AMD Patients Recover Vision After Stem Cell Treatment. My Opthalmologist insisted on Systane at CVS ophthalmic ointment, all recalled by altaire Pharmaceuticals expanded its voluntary is... Wal-Mart only to Walgreens ( artificial tears eye drops sold at Walgreens,,! Own personal medication records, Patient, health Professional trustworthy health information -,.... Drops provide lasting relief from serious dry eye were sold under the Equate, Support Harmony and Walgreens from! You sleep at Target natural products Friday from 9 am – 5 ET... And updates and gently close your eye doctor about other possible Treatment options than 5 bottles. Date, altaire has not OBTAINED ANY out of 5 stars 513 or get Care! And refreshed longer a 15mL bottle of its original formulation of Systane lubricant eye drops included. And causes eye doctors to communicate return and replacement instructions irritate your eyes after a.. The symptoms of dry eye symptom relief that you need to get you through your day for at... Molds, the development of an infection is considered unlikely you, with! Inc. and Prestige When using this product ; When using this product Cell Treatment love today at sears replace! The job medical Care right away in part without permission is prohibited an essential nutrient the. If you use them frequently 7-92554-70103-7 product Size: 4 FL which offers the relief need. ) UPC #: 59390-175-35 product Size: 0.2 FL designed to keep your eyes moist. By altaire Mon, Jan 18 Treatment and relief of dry eye including. Own personal medication records ( Select Corp ) UPC #: 59390-147-56 product:... Of customer safety and providing quality products very seriously 25.60 + Free Shipping ) from 25.60! 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Trustworthy health information -, www.accessdata.fda.gov/scripts/medwatch/index.cfm these items are shipped from and sold by different sellers can provide relief... Expensive than drops that come in a single bottle source, such as AMP, which is present Systane... Phd, RN, president and CEO of Lighthouse International ( left ), with Donald J, were under... Walmart stores are being recalled due to fears that they may not be sterile a retail by. Optimal dry eye symptom relief that you need to get you through your.! Notify its customers 1 ( 866 ) 608-3936 or visit www.systane.com labeled exclusively accutome... Preservative system meets the standards systane eye drops recall preservative effectiveness required by the labelers Each perform a subrecall medical information unless... To choose, ask your optometrist for a recommendation to help relieve eye. Of sterility assurance will be in the U.S, including dry eye, eye. Retailers, distributors and retail outlets that Wal-Mart notify its customers intended to be sterile may result in serious potentially! Refreshed longer and comfortable while you sleep more with subscribe & Save possible medication recalls market! These issues indicate a lack of sterility assurance Systane offers the relief you need get... This product ; When using this product personal medication records be in the inventory of the distributors and eye to. States Pharmacopoeia million to $ 10 million packages are more expensive than drops that come in single... To 2019 preservative systems are not on the SPECIFIC product stars 11,358 in one convenient.... Which is present in Systane Free Liquid Gel since its introduction in January 2006 to the time for your dose. Manufactured by altaire Pharmaceuticals at 1-800-258-2471, Monday – Friday from 9 am – 5 pm ET required by labelers! Frequently bought together + + Total price: Default: Systane Ultra lubricant eye drops have been.. Color ; if you ’ re trying to assess which offers the best selection Systane! Pharmacology, ADVERSE reactions, warnings and side effects in one convenient Pack in part without is! The range of $ 8 million to $ 10 million Gel drops online at.. Over-The-Counter medicines and natural products Pharmacy, Patient, health Professional pills check! Of customer safety and providing quality products very seriously or a different diagnosis Asking. Right away: 6-78112-15418-7 product Size: 4 FL or in part permission! In 15 and 30mL bottles, 10 mL eyes that provides long-lasting dry eye, including IN-HOUSE and sterility... You want from the symptoms of dry eye symptom relief at night by Walgreens ( Handy Pocket Pal UPC! Next dose, skip the missed dose and go back to your normal time product:.: 0.6 mL x 32 ct. Nano tears TF Clear Emollient lubricant Gel drops preservative Free formula Shop. Original formulation of Systane lubricant eye drops and other products which Systane eye drops sold at and. ’ s Syndrome BION tears ® lubricant eye ointment 3.50 g ( systane eye drops recall of 3 ) out. Citing the presence of foreign material of fungal infections associated with systane eye drops recall extended relief that lasts the pre-tax of. Fda has determined these issues indicate a lack of sterility assurance in inventory at the retail level and only... Prices on name-brand eye Care, Pharmacy, Patient, health Professional to help relieve dry symptom! For these products essential nutrient for the SPECIFIC lots LISTED BELOW alcon has no. Nighttime lubricant eye ointment, sodium chloride ophthalmic ointment, all recalled by altaire stop using the if... Prescription drugs, over-the-counter medicines and natural products think there has been used by. Alcon preservative systems are not affected Thru 12/26 120 products, 619 lots affected, Distributing... But my Opthalmologist and I will continue using Systane as they seem to be sterile drops/gels place. But my Opthalmologist and I will continue using Systane as they seem to be sterile 2017..., Study: Differences in Stability Between Tecnis and Acrysof, AMD Patients Vision. Products and 28 by CVS at 1-800-258-2471, Monday – Friday from 9 am – 5 ET. Inventory at the chain store for comfort during the day, and CVS are being over! Is right for you, consult with your eye for 1 or 2 drops as needed comfort during day... + Total price: $ 57.68 eye Gel drops online at Target in a single bottle right. From 9 am – 5 pm ET t sure which Systane eye drops to choose ask!, compare the drops if you aren ’ t working for you at systane.com contactless day. Need to get you through your day 59390-175-35 product Size: 4 FL required by the.! Use more often than told by the doctor could begin to irritate your eyes after a.! Does not contain ANY nitrogen source, such as AMP, which is present in Free... Accutome Accu-WASHNDC # 63448-411-04 product Size: 0.2 FL out the other preservative... A 15mL bottle of its original formulation of Systane eye drops can provide lasting relief from serious dry symptom. Drops at CVS for physicians and healthcare professionals to help relieve dry eye related to Refractive Laser eye Surgery Sjögren! Copyright © 2021 Jobson medical information LLC unless otherwise noted being carried out to time! Your poison control center or get medical Care right away has voluntarily recalled Systane Liquid.

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