TO DATE, ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATION RESULTS, INCLUDING IN-HOUSE AND THIRD-PARTY STERILITY TESTING, FOR THESE PRODUCTS. Check your product package to see when you should discard your preservative-free product. 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. ET. Altaire has also requested that the labelers each perform a subrecall. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets. TO DATE, ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. 4.6 out of 5 stars with 2027 reviews. • Refresh Celluvisc – a thick gel that provides extended relief and coverage of the ocular surface in a non-preserved formulation • Refresh PM – an ointment that provides overnight relief in a non-preserved … The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. REFRESH OPTIVE ADVANCED ® is a lipid-enhanced … ET. Refresh. 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. Oz. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. By submitting this form you are giving Allergan, the makers of REFRESH®, permission to provide you with coupons, promotional offers, eye health information, and relevant product news. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. A very serious allergic reaction to this drug is rare. This one-of-a-kind, patented formula feels like a drop and soothes like a gel … No other lots are being recalled. 2027. Your medication may look different. refresh optive tm gel drops. Usually, drops may be used as often as needed. Where do you typically shop for over-the-counter wellness 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. 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. OZ. For drops/gels, place the dropper directly over the eye and squeeze out 1 or 2 drops as needed. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. (3 days ago) REFRESH OPTIVE ® GEL DROPS is designed to apply like a drop, yet relieve like a gel for soothing comfort and extended relief from moderate symptoms of eye dryness day or night. … Some products contain preservatives that may damage contact lenses or cause irritation in persons with allergies. Many times Refresh Optive (carboxymethylcellulose) … The products are manufactured and labeled exclusively for Wal-Mart. The FDA has determined these issues indicate a lack of sterility assurance. Altaire ships the products labeled for Walgreens only to Walgreens. Use eye drops before eye ointments to allow the eye drops to enter the eye. Follow all directions on the product package. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. 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. Some eye drops need to be shaken before use. Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Coronavirus in Context: Interviews With Experts, Sign Up to Receive Our Free Coroanvirus Newsletter, Treating Opioid Use Disorder With Medications, Constipated? Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday – Friday from 9 am – 5 pm ET. 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. Canada residents can call a provincial poison control center. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. If you have any health problems, consult your doctor or pharmacist before using this product. Otherwise, call a poison control center right away. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. Protect your eyes with a lubricating eye gel that’s thicker than REFRESH OPTIVE FUSION ® and suitable for night-time use. Refresh Optive Gel Drops Extended Therapy, 0.33 Fl Oz (Pack of 2) by Refresh. Select one or more newsletters to continue. No other lots are being recalled. refresh optive ® gel drops. Oz. Did you or will you purchase this product in-store or online? Things to remember when you fill your prescription. Talk to your pharmacist for more details. 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 use Refresh Optive (carboxymethylcellulose) on a regular basis, use a missed dose as soon as you think about it. The photos shown are samples only Not all photos of the drug may be displayed. ... Systane Gel Drops Lubricant Eye Gel … May be used as a protectant against further irritation. Some preservative-free drops that come in single-use vials/droppers should be discarded either immediately after use or up to 12 hours after opening. Refer to storage information printed on the package. Available for Android and iOS devices. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. The FDA has determined these issues indicate a lack of sterility assurance. This recall is being carried out to the retail level and is only for the specific lots listed above. 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. This recall is being carried out to the retail level and is only for the specific lots listed above. If you are using this product under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. To avoid contamination, be careful not to touch the dropper or top of the ointment tube or let it touch your eye. Vision may be temporarily blurred when this product is first used. 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. For an ointment, hold the tube directly over the eye and gently squeeze a small strip (one-fourth of an inch or roughly 6 millimeters) of ointment into the pouch. 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. This medication is used to relieve dry, irritated eyes. Many people using this medication do not have serious side effects. Altaire ships the products labeled for CVS only to CVS. lubricant eye gel. Oz. Condition is "New with tags". Always replace the cap tightly after each use. Certain brands (containing glycerin with polysorbates, among other ingredients) may have a milky appearance. Altaire takes its mission of customer safety and providing quality products very seriously. TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. In Canada - Call your doctor for medical advice about side effects. Purite ® breaks down into natural tear components when administered to the eye – that’s … 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.). US residents can call their local poison control center at 1-800-222-1222. The products are manufactured and labeled exclusively for CVS Health. 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. REFRESH LIQUIGEL ® Lubricant Eye Gel provides fact-acting relief and soothing comfort for more moderate symptoms of eye dryness day or night. Product Description: Clear Eyes Redness Relief (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. 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. A Retail Level recall is limited to product lots currently in inventory on hand at any distributor to which Altaire Pharmaceuticals, Inc. has sold these products. In addition, we may … This medication is usually used only as needed. REFRESH ® Brand Lubricant Eye Drops come in a variety of … NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct. Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free. 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. by Target Corp. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Shipped with USPS First Class. Check the package to see if you can wear your contact lenses while using your product. Selected from data included with permission and copyrighted by First Databank, Inc. If you have any questions, ask your doctor or pharmacist. It features … The products are distributed at the retail level by the labelers identified herein. 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. If you have … Original strength formula alleviates discomfort and … Look down and gently close your eye for 1 or 2 minutes. 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. 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. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. Ointments are usually used 1 to 2 times daily as needed. 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. 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. How frequently do you purchase this product? The FDA has determined these issues indicate a lack of sterility assurance. GENERIC NAME(S): Carboxymethylcellulose-Glycern. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. 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. 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. Tilt your head back, look up, and pull down the lower eyelid to make a pouch. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. 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. Altaire takes its mission of customer safety and providing quality products very seriously. Read honest and unbiased product reviews from our users. 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. Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other eye medications. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. A Retail Level recall is limited to product lots currently in inventory at the chain store. Release the eyelid, close the eye, and slowly roll your eye in all directions to spread the medication. For the latest FDA MedWatch alerts, go here. 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. Oz. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Look down and gently close your eye for 1 or 2 minutes. Place one finger at the corner of the eye near the nose and apply gentle pressure. 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. 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