Clear Eyes® Redness Relief Get relief from irritation, redness, burning and mild dry eyes with Clear Eyes Redness Relief eye drops; for redness due to minor irritations. The products are distributed at the retail level by the labelers identified herein. • 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. Accutome Accu-WASHNDC# 63448-411-04 Product Size: 4 FL. TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. OZ. Ingestion of only a small amount (1-2 mL; for reference, there are 5 mL in a teaspoon) of the eye drops or nasal spray can lead to serious adverse events in young children. FDA does not endorse either the product or the company. For external use only. 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. Product Size: 15 mL, Product Description: Grandall Colirio Oftal-Mycin Redness Relief Eye Drops https://www.webmd.com/drugs/2/drug-148415/clear-eyes-redness-relief/details Oz. 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. Product Size: 15mL, Product Description: Grandall Oftal-Mycin Ophthalmic Ointment Ask a Question/Reply. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. When we are notified of a product recall, all store and distribution centers follow proper protocols to ensure that the affected products are not on our shelves. Clear Eyes Redness .5oz Recall – 01/17/19 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. TRP The FDA Alert(s) below may be specifically about Clear Eyes Redness Relief or relate to a group or class of drugs which include Clear Eyes Redness Relief (naphazoline). Do not use. Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 oz. Lubricant/Redness Reliever Eye Drops Up to 8 Hours of Soothing Comfort Relieves Redness Soothes & Moisturizes Fast Acting A Sterile Buffered Solution Clear Eyes® Redness Relief is formulated both to relieve redness and moisturize. UPC#: 6-78112-15418-7   Product Size: 0.2 FL. From the #1 brand in redness relief, Clear Eyes® has a variety of products to help relieve your red eyes. Cancel Post Message. RECALL: Clear Eyes Redness Relief 15 ml Date of recall: 7/17/2019 UPC code: 6-78112-25415-6 Lot codes: Lot # 16195 Expiration Date – 7/19; Lot # 16211 Expiration Date – 8/19; Lot # 16216 Expiration Date – 8/19 Manufacturer of item: Altaire Pharmaceuticals, Inc. Toll free number of manufacturer for information & questions: 973.984.1669 Reason for […] Altaire has also requested that the labelers each perform a subrecall. A pharmaceutical company has announced a voluntary recall of its over-the-counter eye drops sold at CVS Pharmacies due to concerns with sterility. Seasonal – UPC # 6-78112-65920 Please note: Product packaging as shipped, may not match image on website due to packaging updates. Clear Eyes: Redness Relief, 15 ml and 30 ml; Redness Relief (Handy Pocket Pal), 0.2 fluid ounces; Redness Relief (Little Drug) 0.2 fluid ounces; Redness Relief (Select Corp), 0.2 fluid ounces. Additional information on recalled products is available through www.recalls.gov. For years, patients have come to him wanting a way to get rid of redness. ... CVS Health Maximum Redness Relief Eye … Clear Eyes Redness Relief Eye Drops Handy Pocket Pal 0.20 oz (12 Pack) 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. Side Effects & Adverse Reactions. The FDA has determined these issues indicate a lack of sterility assurance. Using eye drops contaminated with pathogens, like bacteria or fungi, can lead to serious infections of the eye. Message. These products are sold under various brand names, as generics, and as store brands (see List of Products, included in the Drug Safety Communication, below). ISSUE: FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious and life-threatening adverse events. Ask a Question. Relieves redness due to minor irritations Helps protect against further irritations Soothes and moisturizes to relieve redness due to irritation, burning, and mild dry eyes From the #1 brand of redness relief eye drops Provides up to 12 hours of soothing comfort The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. Spreadsheet with details We have a Google sheet including all the products, lot numbers and FDA links and will continue to update that as well as this page should … This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. 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. Withdrawals, & Oz. 4.4 out of 5 stars 24. We comply with the HONcode standard for trustworthy health information -, www.accessdata.fda.gov/scripts/medwatch/index.cfm, Consumer Update: Drops, Sprays Put Curious Kids at Risk, Clear Eyes + Redness Relief Consumer Information, Redness Relief Eye Drops Consumer Information. Clear Eyes Redness Relief (Select Corp) , Product Size: 0.2 oz. UPC#: 6-55708-01039-6  Product Size: 0.2 FL. These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings. While suffering from red, itching, and/or irritated eyes, many of us never hesitate to reach for “Redness Relief Eye Drops.” These drops (the most popular brands being Visine, Clear Eyes, B&L advanced redness relief) are known for temporary relief of minor eye redness or discomfort caused by minor irritants. No other lots are being recalled. 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. $20.15 $ 20. Clear Eyes Redness Relief, Product Size: 30 mL. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. Add Recall Info. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets. Add Info. Altaire has also requested that the labelers each perform a subrecall. Clear Eyes Redness Relief (Select Corp) UPC#: 6-55708-01039-6 Product Size: 0.2 FL. 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. Equate Comfort Gel Lubricant Eye Gel Twin Pack: 49035-197-49. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. 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. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal) Clear eyes redness relief eye drops relieve redness from minor irritations and protect against further irritations Soothes and moisturizes to relieve redness Helps irritation, burning, and mild dry eyes From the number 1 brand of eye drops Provides up to 12 hours of soothing comfort; Pack of 3 Ask a Question. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Equate Eye Allergy Relief Drops: 49035-887-13. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Clear Eyes Redness Relief up to 8 Hours, Handy Pocket Pals Travel Size: 12 Packs of 0.2 Fl Oz - Tj10. Equate Sterile Lubricant Stye Ointment: 49035-875-50. NDC# 15821-101-15 Product Size: 15 mL, Product Description: Grandall Colirio Ojo De Aguila Eye Drops The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. [10/25/2012 - Consumer Update: Drops, Sprays Put Curious Kids at Risk - FDA]. Product Description: Clear Eyes Redness Relief (Little Drug) The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. Product Recalls Market Basket takes food safety very seriously. Oz. ... Clear Eyes. Altaire has initiated a Retail Level recall for the Clear Eyes – Eye Drops due to management concerns regarding the sufficiency of Quality Assurance control over critical systems in the manufacturing facility Product Name UPC Clear Eyes® Redness Relief Handy Pocket Pal® 6-78112-25418-7 Clear Eyes® Maximum Itchy Eye Relief 6-78112-65920-3 Clear Eyes® Maximum Redness Relief Clear Eyes Redness Relief Recall. Clear Eyes Cooling Redness Relief Recall. No other lots are being recalled. Cancel Post Info. Comment. TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. Do not use if. 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. 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Cancel Post Info. Product Description: Accutome Accu-WASH CLEAR EYES MAXIMUM REDNESS RELIEF- naphazoline hydrochloride and glycerin liquid If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will … This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Date of recall: 7/26/2019 UPC codes: Max Redness – UPC # 6-78112-66577-8. [10/25/2012 - List of Products - FDA] CLEAR EYES REDNESS RELIEF prescription and dosage sizes information for physicians and healthcare professionals. Oz. Cancel Post Message. A recall has been issued for a brand of eye drops and ointments sold at Walmart and Walgreens, which the federal government says is not sterile and could lead to … Ask a Question/Reply. UPC#: 6-78112-25419-4  Product Size: 30 mL. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. Select one or more newsletters to continue. The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. Rather than applying Clear Eyes, a sterile purified water product is optimal for cleaning and soothing your dog’s eyes due to, for example, irritation caused by dry mucous. Lubricant/Redness Reliever Eye Drops; Reduces Redness; Soothes & Moisturizes; Fast Acting; Sterile Safety Alerts, Accutome, Focus Laboratories, Grandall Distributing Co. Inc. , Prestige, An official website of the United States government, : Product Description: Clear Eyes Redness Relief (Select Corp)UPC#: 6-55708-01039-6 Product Size: 0.2 FL. Maximum Redness Relief Eye Drops. Relieves redness of the eye due to minor eye irritations. Bottle size: OTC eye-drops for redness relief are sold in 0.25 ml, 0.05 ml, 0.75 ml, and 0.80 ml plastic squeeze bottles or glass containers. NDC# 63448-411-04 Product Size: 4 FL. 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. Clear Eyes Is Not Recommended For Dogs. Before sharing sensitive information, make sure you're on a federal government site. Questions & Answers. UPC#: 6-78112-25415-6 Product Size: 15 mL, Product Description: Clear Eyes Redness Relief if solution changes color or becomes cloudy. Add Info. Only 14 left in stock - order soon. 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. “Most commonly, this would be in the form of an infectious corneal ulcer. Questions & Answers. Clear Eyes Redness Relief, Product Size: 15 mL. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The site is secure. Comment. Product Description: FreshKote Lubricant Eye Drops We will constantly update this page to keep our customers informed. Artificial tear drops are usually OK, but it really depends on what’s in the formula as well as your objective. The products are distributed at the retail level by the labelers identified herein. Altaire Pharmaceuticals Inc. issued voluntary recalls for various Equate products, including for allergy relief, solutions, eye drops and gel drops – all manufactured and labeled for Walmart. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. Available for Android and iOS devices. 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 following FDA safety notices may be specifically about Clear Eyes Redness Relief or relate to a group or class of drugs which include Clear Eyes Redness Relief (naphazoline). Relieves red eyes, plus relieves dryness, burning, and other irritations. RECALL: Clear Eyes Max Redness .5 oz & Clear Eyes Seasonal .5 oz. For external use only. 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. Altaire takes its mission of customer safety and providing quality products very seriously. 15 ($8.40/Fl Oz) FREE Shipping. Audience: Consumer, Health Professional, Pharmacy. NEW Clear eyes ® COOLING COMFORT Lubricant/Redness Relief Eye Drops REDNESS RELIEF Cools Eye Irritations Relieves Redness STERILE 0.5 FL OZ (15 ML) INGREDIENTS AND APPEARANCE CLEAR EYES COOLING REDNESS RELIEF glycerin and naphazoline hydrochloride liquid This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Oz. More Recalls, Market BACKGROUND: Most of these redness-relief eye drops and nasal decongestant sprays currently do not come packaged with child-resistant closures, so children can accidentally ingest the drug if the bottles are within easy reach. If a child accidentally swallows these eye drops or nasal decongestant spray, call the National Capital Poison Center (1-800-222-1222) and seek emergency medical care immediately. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Clear Eyes Redness Relief (Little Drug), Product Size: 0.2 oz. Get an alert when a recall is issued. Altaire takes its mission of customer safety and providing quality products very seriously. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets. Oz. Get an alert when a recall is issued. Eye drops packaged in 0.80 ml or larger bottles usually include an eye dropper. Pharmacology, adverse reactions, warnings and side effects. UPC#: 7-92554-70103-7 Product Size: 0.2 FL. The FDA has determined these issues indicate a lack of sterility assurance. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Over-The-Counter Ophthalmic Products Sold By Accutome, Focus Laboratories, Grandall Distributing Co. Inc. And Prestige, Recent Recalled Product Photos on FDA's Flickr Photostream. ET. 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. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. OZ. Message. 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: [10/25/2012 - Drug Safety Communication - FDA] Product Description: Clear Eyes Redness Relief (Select Corp) Product Description: Clear Eyes Redness Relief (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. Oz. No deaths were reported; however, serious events requiring hospitalization such as nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma have occurred. Clear Eyes Redness Drops Recall Items Recalled: LOT #16195, EXPIRATION DATE 7/19 LOT #16211, EXPIRATION DATE 8/19 LOT #16216, EXPIRATION DATE 8/19 Reason For Recall: DUE TO LACK OF STERILITY ASSURANCE. Side Effects & Adverse Reactions. Product Size: 3.5 g, Product Description: Clear Eyes Redness Relief The following products are affected by this recall: Clear Eyes© Redness Relief, 0.5 fluid ounce: UPC: 6-78112-25415-6 with lot number 16195 and expiration date of July 2019; with lot number 16211 and expiration date of Aug. 2019; with lot number 16216 and expiration date of Aug. 2019 Clear Eyes© Redness Relief, 1 fluid ounce: UPC: 6-78112-25419-4 For use as a protectant against further irritation or dryness of the eye.For the temporary relief of burning and irritation due to dryness of the eye. For the latest FDA MedWatch alerts, go here. 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. RECOMMENDATION: Consumers should store these products out of reach of children at all times. No other lots are being recalled. 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