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). UPC#: 6-78112-25419-4  Product Size: 30 mL. The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. Clear Eyes Is Not Recommended For Dogs. Clear Eyes Redness Relief, Product Size: 15 mL. 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 Before sharing sensitive information, make sure you're on a federal government site. Get an alert when a recall is issued. Clear Eyes Redness Relief (Select Corp) UPC#: 6-55708-01039-6 Product Size: 0.2 FL. UPC#: 6-55708-01039-6  Product Size: 0.2 FL. if solution changes color or becomes cloudy. 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 … 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. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Altaire has also requested that the labelers each perform a subrecall. UPC#: 6-78112-15418-7   Product Size: 0.2 FL. Product Description: Accutome Accu-WASH Side Effects & Adverse Reactions. Date of recall: 7/26/2019 UPC codes: Max Redness – UPC # 6-78112-66577-8. Questions & Answers. Cancel Post Info. Do not use. 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. 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. 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. Audience: Consumer, Health Professional, Pharmacy. Equate Sterile Lubricant Stye Ointment: 49035-875-50. Questions & Answers. 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. Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 oz. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Altaire takes its mission of customer safety and providing quality products very seriously. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal) TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. Equate Comfort Gel Lubricant Eye Gel Twin Pack: 49035-197-49. 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). 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. [10/25/2012 - List of Products - FDA] Equate Eye Allergy Relief Drops: 49035-887-13. Oz. Clear Eyes Cooling Redness Relief Recall. RECALL: Clear Eyes Max Redness .5 oz & Clear Eyes Seasonal .5 oz. Add Recall Info. [10/25/2012 - Consumer Update: Drops, Sprays Put Curious Kids at Risk - FDA]. 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 Product Description: Clear Eyes Redness Relief (Select Corp)UPC#: 6-55708-01039-6 Product Size: 0.2 FL. Additional information on recalled products is available through www.recalls.gov. Relieves red eyes, plus relieves dryness, burning, and other irritations. The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. No other lots are being recalled. 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). Clear Eyes Redness Relief Eye Drops Handy Pocket Pal 0.20 oz (12 Pack) Clear Eyes Redness Relief (Little Drug), Product Size: 0.2 oz. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. The site is secure. We will constantly update this page to keep our customers informed. 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. RECOMMENDATION: Consumers should store these products out of reach of children at all times. Ask a Question. Oz. 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. Product Size: 15 mL, Product Description: Grandall Colirio Oftal-Mycin Redness Relief Eye Drops Pharmacology, adverse reactions, warnings and side effects. Oz. The FDA has determined these issues indicate a lack of sterility assurance. Comment. These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings. Ask a Question. 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. https://www.webmd.com/drugs/2/drug-148415/clear-eyes-redness-relief/details Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 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. CLEAR EYES REDNESS RELIEF prescription and dosage sizes information for physicians and healthcare professionals. 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. ET. 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. 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. From the #1 brand in redness relief, Clear Eyes® has a variety of products to help relieve your red eyes. More Recalls, Market Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Add Info. Oz. NDC# 63448-411-04 Product Size: 4 FL. NDC# 15821-101-15 Product Size: 15 mL, Product Description: Grandall Colirio Ojo De Aguila Eye Drops Product Recalls Market Basket takes food safety very seriously. Do not use if. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. For years, patients have come to him wanting a way to get rid of redness. Using eye drops contaminated with pathogens, like bacteria or fungi, can lead to serious infections of the eye. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. Clear Eyes Redness Relief, Product Size: 30 mL. Artificial tear drops are usually OK, but it really depends on what’s in the formula as well as your objective. 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 (Little Drug)UPC#: 7-92554-70103-7 Product Size: 0.2 FL. 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. Get an alert when a recall is issued. Product Size: 15mL, Product Description: Grandall Oftal-Mycin Ophthalmic Ointment The products are distributed at the retail level by the labelers identified herein. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. ... Clear Eyes. A Retail Level recall is limited to product lots currently in the inventory of the distributors and retail outlets. 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 … Product Size: 3.5 g, Product Description: Clear Eyes Redness Relief Add Recall Info. Comment. 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. 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 Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. OZ. 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. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. “Most commonly, this would be in the form of an infectious corneal ulcer. For external use only. Cancel Post Message. Product Description: Clear Eyes Redness Relief (Little Drug) The products are distributed at the retail level by the labelers identified herein. 15 ($8.40/Fl Oz) FREE Shipping. ... CVS Health Maximum Redness Relief Eye … The FDA has determined these issues indicate a lack of sterility assurance. UPC#: 6-78112-25415-6 Product Size: 15 mL, Product Description: Clear Eyes Redness Relief $20.15 $ 20. Oz. FDA does not endorse either the product or the company. Product Description: Clear Eyes Redness Relief (Select Corp) • 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. 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 […] MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Relieves redness of the eye due to minor eye irritations. The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. No other lots are being recalled. Clear Eyes Redness Relief Recall. Oz. ET. A pharmaceutical company has announced a voluntary recall of its over-the-counter eye drops sold at CVS Pharmacies due to concerns with sterility. For the latest FDA MedWatch alerts, go here. Select one or more newsletters to continue. Cancel Post Info. 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. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. 4.4 out of 5 stars 24. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. 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 MAXIMUM REDNESS RELIEF- naphazoline hydrochloride and glycerin liquid If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will … Seasonal – UPC # 6-78112-65920 Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. No other lots are being recalled. Only 14 left in stock - order soon. UPC#: 7-92554-70103-7 Product Size: 0.2 FL. Ask a Question/Reply. TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. 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. Lubricant/Redness Reliever Eye Drops; Reduces Redness; Soothes & Moisturizes; Fast Acting; Sterile Product Description: FreshKote Lubricant Eye Drops 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. Safety Alerts, Accutome, Focus Laboratories, Grandall Distributing Co. Inc. , Prestige, An official website of the United States government, : Accutome Accu-WASHNDC# 63448-411-04 Product Size: 4 FL. TRP Withdrawals, & 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] Altaire has also requested that the labelers each perform a subrecall. 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. 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. 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. Add Info. Clear Eyes Redness Relief up to 8 Hours, Handy Pocket Pals Travel Size: 12 Packs of 0.2 Fl Oz - Tj10. 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. Maximum Redness Relief Eye Drops. 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 OZ. Please note: Product packaging as shipped, may not match image on website due to packaging updates. 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. Clear Eyes Redness Relief (Select Corp) , Product Size: 0.2 oz. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Oz. The .gov means it’s official.Federal government websites often end in .gov or .mil. Available for Android and iOS devices. Altaire takes its mission of customer safety and providing quality products very seriously. Message. 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. Ask a Question/Reply. 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. Eye drops packaged in 0.80 ml or larger bottles usually include an eye dropper. 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. 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. For external use only. 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. Message. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. Cancel Post Message. Side Effects & Adverse Reactions. 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Cvs Health Maximum Redness Relief ( Select Corp ) UPC # 6-78112-65920 Relieves of. Notices may include a list of possible medication recalls, market withdrawals, alerts and warnings purposes and. Federal government site the cases of accidental ingestion reviewed by FDA occurred in children 5 years of and... Intended for medical advice, diagnosis or treatment drops are usually OK, but really! Depends on what ’ s official.Federal government websites often end in.gov or.mil Laboratories, Distributing.

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