Many times Systane Ultra (artificial tears eye drops) is used on an as needed basis. No other lots are being recalled. 00 ($28.79/Fl Oz) Save 5% more with Subscribe & Save. The products are distributed at the retail level by Wal-Mart. 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. 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. Altaire ships the products labeled for Wal-Mart only to Wal-Mart. OTC product types include: lubricant eye drops and gels, allergy drops, redness relievers, lubricating ointments, sodium chloride ointments and solutions, and eye … This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Two great 10 mL products in one convenient pack. Other Systane formulations are not affected, and no ocular infections due to the recalled product have been reported. The product is distributed only in the … 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. 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. The company is currently contacting retailers, distributors and eye doctors to communicate return and replacement instructions. Side Effects & Adverse Reactions. SofZia preservative system meets the standards of preservative effectiveness required by the United States Pharmacopoeia. Product Description: Clear Eyes Redness Relief (Select Corp)UPC#: 6-55708-01039-6 Product Size: 0.2 FL. For the latest FDA MedWatch alerts, go here. No other lots are being recalled. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Do not use 2 doses at the same time or extra doses. 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. If you think there has been an overdose, call your poison control center or get medical care right away. Altaire takes its mission of customer safety and providing quality products very seriously. Accutome Accu-WASHNDC# 63448-411-04 Product Size: 4 FL. It forms a smooth, protective layer for the eyes that provides long-lasting dry eye symptom relief at night. Some eye drops and ointments sold over-the-counter at major retailers are being recalled due to fears that they may not be sterile. However, because of the characteristics of these molds, the development of an infection is considered unlikely. Tara Cortes, PhD, RN, president and CEO of Lighthouse International (left), with Donald J. The products are manufactured and labeled exclusively for Walgreens. Shop for systane gel drops online at Target. Customers with questions regarding this recall can contact 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. Frequently bought together + + Total price: $57.68. 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. Do not use more often than told by the doctor. Alcon has distributed over 5 million bottles of Systane Free LIQUID GEL since its introduction in January 2006. TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. 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. $19.00 $ 19. Systane Ultra Lubricant Eye Drops are clinically proven to deliver extended protection and high-performance relief from your dry eye symptoms. 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. 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. 96 … It has also recalled a variety of products sold by CVS. 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 . Ask a Question. The FDA has determined these issues indicate a lack of sterility assurance. 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. No other formulations of Systane ® lubricant eye drops are included in this recall. Provides soothing relief from serious dry eye, including Dry Eye related to Refractive Laser Eye Surgery & Sjögren’s Syndrome. Alcon has demonstrated that the sofZia preservative system withstands multiple challenges of high-levels of ocular pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus niger. No other formulations of Systane ® lubricant eye drops are included in this recall. Great deal on Systane Ultra Eye Drops at CVS. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. 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 … Ptosis or a Different Diagnosis: Asking the Right Questions Before Treatment. OZ. Do not use. This product is distributed only in the U.S, including Puerto Rico. 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. It is also Preservative-Free. 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. 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. if this product changes color; if you are sensitive to any ingredient in this product; When using this product. 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. 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. 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. Find a great collection of Eyes Systane Eye Care at Costco. Some eye drops and ointments sold over-the-counter at major retailers are being recalled due to fears that they may not be sterile. Use SYSTANE ULTRA for comfort during the day, and SYSTANE Gel Drops for extra protection at night. recalls In a nutshell. Preservative free formula minimizes irritation. Get the Systane Eye Drops you want from the brands you love today at Sears. BACKGROUND: Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box. Walgreens, which operates as the second-largest pharmacy store chain in the U.S., is also recalling some of its over-the-counter eye drops and opthalmic ointments. ET. Many times Systane (artificial tears eye drops) is used on an as needed basis. Learn about SYSTANE® eye drops, eye care products, and important information about dry eye symptom relief. Find the SYSTANE® product that is right for you at systane.com. 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. 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 are manufactured and labeled exclusively for Wal-Mart. This recall is in response to 11 consumer reports citing the presence of foreign material. 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. The FDA has determined these issues indicate a lack of sterility assurance. Systane eye drops ingredients may vary based on the specific product. 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. NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free. This voluntary recall is in response to 11 consumer reports citing the presence of foreign material. 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. Altaire Pharmaceuticals expanded its voluntary recall of multiple eye drops and other products. equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) - Distributed by Wal-Mart Stores, Inc. 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. Therefore, the recall applies only to Systane Free Liquid Gel. OTC product types include: lubricant eye drops and gels, allergy drops, redness relievers, lubricating ointments, sodium chloride ointments and solutions, and eye … The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. 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. Systane lubricant eye drops use the original formulation that made the Systane family of products the #1 doctor recommended brand for dry eye relief. recalls In a nutshell. Get an alert when a recall is issued. The company estimates that the pre-tax cost of the recall will be in the range of $8 million to $10 million. Last month, Alcon voluntarily recalled Systane Free Liquid Gel lubricant eye drops. SYSTANE ULTRA Lubricant Eye Drops are clinically proven to deliver high-performance dry eye symptom relief that lasts. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. ET. Systane Ultra Eye Drops Lubricant High Performance. If you’re trying to assess which offers the best value, compare the drops based on the price per ounce. CVS: Systane Ultra Eye Drops ONLY $4.34 Each Thru 12/26. Cheaper eye drops are available but my Opthalmologist insisted on Systane. Altaire ships the products labeled for Walgreens only to Walgreens. 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. No other lots are being recalled. 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. 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. No other formulations of Systane ® lubricant eye drops are included in this recall. NDC#: 59390-141-56 Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, NDC#: 59390-142-49 Product Size: 2 x 15 mL, Nano Tears TF Clear Emollient Lubricant Gel Drops, Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, NDC#: 59390-143-51 Product Size: 2 x 10 mL, Nano Tears XP Clear Emollient Lubricant Gel Drops, Altaire Ofloxacin 0.3% Ophthalmic Solution USP, ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF, ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF, ActivEyes Lubricant Eye Ointment Preservative Free, NDC#: 59390-189-50 Product Size: 3.5 gram. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. ISSUE:  Altaire Pharmaceuticals, Inc., announced that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. Systane ® BION TEARS ® Lubricant Eye Drops Soothing relief for serious dry eye related to Laser Eye Surgery. last updated 7/24/2019. If you use Systane Ultra (artificial tears eye drops) on a regular basis, use a missed dose as soon as you think about it. The products are distributed at the retail level by CVS. Reproduction in whole or in part without permission is prohibited. Shop for systane restorative eye drops online at Target. Pharmacology, adverse reactions, warnings and side effects. Systane Long Lasting Lubricant Eye Drops Vials Eye Drops, 30 Count, 0.7-mL Each. NDC#: 59390-175-35 Product Size: 4 Fl. 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. 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. In stock on January 21, 2021. 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. A number of eye drops and opthalmic ointments sold at Walgreens and Walmart stores are being recalled over concerns they may not be sterile. Extended protection fast symptom relief. Alcon has distributed over 5 million bottles of Systane ® Free LIQUID GEL since its introduction in January 2006. 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. TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. 4.8 out of 5 stars 1,952. Other in-use testing with high level challenges of Fusarium solani, Ralstonia pickettii, Staphylococcus epidermidis, Streptococcus pneumoniae, and Haemophilus influenzae demonstrated that Travatan Z solution is effectively preserved. 14 brands, 120 products, 619 lots affected. Learn more at systane.com. Choose from contactless Same Day Delivery, Drive Up and more. If you aren’t sure which Systane eye drops to choose, ask your optometrist for a recommendation. D'Amico, MD. 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.). 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. 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 … 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. Eye drop recall . The products, manufactured by Altaire Pharmaceuticals, were sold under the Equate, Support Harmony and Walgreens brands from 2017 to 2019. Do not use more often than told by systane eye drops recall FDA has determined issues! For CVS only to Systane Free Liquid Gel with a 15mL bottle of original., Monday – Friday from 9 am – 5 pm ET drops are included in this product changes color if. 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