Equate Comfort Gel Lubricant Eye Gel Twin Pack: 49035-197-49. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings. 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. Message. 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. Lubricant/Redness Reliever Eye Drops; Reduces Redness; Soothes & Moisturizes; Fast Acting; Sterile Comment. 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 Is Not Recommended For Dogs. Clear Eyes Redness Relief (Little Drug), Product Size: 0.2 oz. Clear Eyes Redness Relief Recall. Maximum Redness Relief Eye Drops. Product Recalls Market Basket takes food safety very seriously. if solution changes color or becomes cloudy. The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. 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. Oz. RECOMMENDATION: Consumers should store these products out of reach of children at all times. More Recalls, Market 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Product Size: 3.5 g, Product Description: Clear Eyes Redness Relief Equate Eye Allergy Relief Drops: 49035-887-13. 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. 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. Relieves red eyes, plus relieves dryness, burning, and other irritations. 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 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. 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). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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] Oz. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. Seasonal – UPC # 6-78112-65920 Oz. UPC#: 6-78112-25415-6 Product Size: 15 mL, Product Description: Clear Eyes Redness Relief 4.4 out of 5 stars 24. 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. A pharmaceutical company has announced a voluntary recall of its over-the-counter eye drops sold at CVS Pharmacies due to concerns with sterility. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. Do not use if. Product Size: 15 mL, Product Description: Grandall Colirio Oftal-Mycin Redness Relief Eye Drops ... CVS Health Maximum Redness Relief Eye … The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility. Select one or more newsletters to continue. Eye drops packaged in 0.80 ml or larger bottles usually include an eye dropper. Ask a Question. Add Recall 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. Withdrawals, & 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 … 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 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 carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. For the latest FDA MedWatch alerts, go here. Safety Alerts, Accutome, Focus Laboratories, Grandall Distributing Co. Inc. , Prestige, An official website of the United States government, : 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). Cancel Post Info. FDA does not endorse either the product or the company. • 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. Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 oz. For external use only. Pharmacology, adverse reactions, warnings and side effects. Side Effects & Adverse Reactions. UPC#: 6-78112-25419-4  Product Size: 30 mL. Clear Eyes Redness Relief (Select Corp) UPC#: 6-55708-01039-6 Product Size: 0.2 FL. Get an alert when a recall is issued. “Most commonly, this would be in the form of an infectious corneal ulcer. The FDA has determined these issues indicate a lack of sterility assurance. Relieves redness of the eye due to minor eye irritations. Oz. UPC#: 6-55708-01039-6  Product Size: 0.2 FL. Cancel Post Message. Side Effects & Adverse Reactions. We will constantly update this page to keep our customers informed. For years, patients have come to him wanting a way to get rid of redness. 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. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. 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. Do not use. Using eye drops contaminated with pathogens, like bacteria or fungi, can lead to serious infections of the eye. 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 … Additional information on recalled products is available through www.recalls.gov. OZ. 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. NDC# 15821-101-15 Product Size: 15 mL, Product Description: Grandall Colirio Ojo De Aguila Eye Drops Altaire has also requested that the labelers each perform a subrecall. Product Description: Accutome Accu-WASH The site is secure. TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS. Oz. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal) Date of recall: 7/26/2019 UPC codes: Max Redness – UPC # 6-78112-66577-8. This recall is being carried out to the RETAIL LEVEL and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. [10/25/2012 - List of Products - FDA] TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS. Only 14 left in stock - order soon. Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)UPC#: 6-78112-15418-7 Product Size: 0.2 FL. For external use only. Product Description: Clear Eyes Redness Relief (Select Corp)UPC#: 6-55708-01039-6 Product Size: 0.2 FL. TRP Get an alert when a recall is issued. ET. 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. 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 up to 8 Hours, Handy Pocket Pals Travel Size: 12 Packs of 0.2 Fl Oz - Tj10. Questions & Answers. ... Clear Eyes. 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. 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. Questions & Answers. Artificial tear drops are usually OK, but it really depends on what’s in the formula as well as your objective. Oz. 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 […] 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 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). 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. 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 … The FDA has determined these issues indicate a lack of sterility assurance. Audience: Consumer, Health Professional, Pharmacy. $20.15 $ 20. UPC#: 7-92554-70103-7 Product Size: 0.2 FL. 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 Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige only to Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige, respectively. 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. Add Info. Clear Eyes Redness Relief (Select Corp) , Product Size: 0.2 oz. No other lots are being recalled. The products are distributed at the retail level by the labelers identified herein. 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. 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