The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections Oct 31, 2023 | Audience: Consumer, Health Professional, Ophthalmology, Pharmacy If you are aged 50 or over and experiencing symptoms like itchy, sore, gritty, and red eyes, you’re not alone. Many people aged 50+ experience these troublesome symptoms daily, in fact, dry eyes affect 30% of adults aged 50 and over. TheraTears® has developed a 50+ eye treatment that is specially designed to soothe, restore and hydrate dry, tired or irritated mature eyes. to make sure that it is safe for you to take TheraTears Nighttime (carboxymethylcellulose) with all of your drugs and health problems. Do not start, stop, or change the dose of If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

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Hydroxypropyl guar is a viscous protein polymer derived from beans. Upon instillation, hydroxypropyl guar forms a soft gel with increased viscosity at the tear pH. It mimics the properties of mucin layer by strengthening the attachment of the aqueous layer to the mucins and promotes the retention of other demulcents [ 20, 21]. It has also been shown to stabilize the tear film. Hydroxypropyl guar is present in all Systane ® brand artificial tears ( Table 3). Artificial tears contain one or more FDA-approved demulcents as active ingredient [ 8]. FDA defines demulcent as a primarily water-soluble polymer, which is applied topically to the eye to protect and lubricate mucous membrane surfaces and relieve dryness and irritation. The list of these demulcents and their concentration range was provided by the FDA in a 1988 monograph to help reduce the costs and expedite approval of artificial tears [ 8]. The FDA approved demulcents include (a) Cellulose derivatives: Carboxymethylcellulose (CMC), Hydroxypropyl methylcellulose (hypromellose), Hydroxyethylcellulose, Methylcellulose, (b) Dextran 70, (c) Gelatin, (d) Polyols: Glycerin, Polyethylene glycol (300, 400), Polysorbate 80, (e) polymers: Polyvinyl alcohol, Polyvinyl pyrrolidone (povidone). Preservative-free eye drops. This type has fewer additives and is generally recommended if you apply artificial tears more than four times a day, or if you have moderate or severe dry eyes. Preservative-free eye drops may come in single-dose vials. It is pertinent to be mindful of the over-the-counter eye drop recalls. Consult the FDA list of affected drops, or ask your eye care practitioner if your drops are safe to use if you’re unsure,” urges Melissa Barnett, OD, director of optometry at UC Davis in California. “An increased risk of infection and potentially vision loss may occur if contaminated drops are used.” A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/ tongue/throat), severe dizziness, trouble breathing.

Tell your doctor right away if you have any serious side effects, including: eye pain, change in vision, continued eye redness/irritation. doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Brimonidine Tartrate Ophthalmic Solution, 0.15%, NDC numbers 60505-0564-1, 60505-0564-2 and 60505-0564-3.

You or your doctor can also report adverse events or quality issues to the FDA’s MedWatch Adverse Event Reporting program.

Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons Nov 13, 2023 | Audience: Consumers WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your The goal of screening the marketed artificial tear formulations was to give health care providers a formulary of artificial tears classified based on their active ingredients and biologically active excipients. The options of preservative-free single dose units, if available, has also been included in our data tables. The compiled information should assist the healthcare providers to make a stepwise and rational selection of appropriate artificial tears for the patients based on the active ingredients and biologically active excipients.

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This makes TheraTears ® your one-stop drop. Developed with clinical experts, our drops contain naturally derived ingredients and offer lasting comfort. They will help you to live your life to the fullest without experiencing the pain and inconvenience of dry eyes. Apply 2 drops into each eye, one or more times a day every few hours or otherwise stated by an healthcare professional. Our screen eye protection drops contain hyaluronic acid 0.1%, a trusted ingredient when it comes to eye lubrication. Found naturally in many areas of the body, including the eyes, skin and joints, this substance helps to keep your eyes feeling moist and fresh. Preservative-free on the eye Clear Eyes Once Daily, Eye Allergy Itch Relief: Lot 114349, Lot 117396, Lot 0120128, Lot 114371, and Lot 123781. Be sure you know how long you can store TheraTears Nighttime (carboxymethylcellulose) before you need to throw it away.

As well as helping your eyes to feel better, these drops can also make them look brighter and healthier. The product contains Euphrasia, also known as eyebright. This natural plant extract supports eye whitening. A lasting soothing effect The company issued a voluntary recall after FDA investigators found unsanitary conditions, which poses a potential risk of eye infections or other eye-related issues. Previous eye drop products that were slapped with recalls in March, May, August and October of this year were due to either bacterial contamination or unsanitary conditions; they were sold at popular retailers such as CVS, Target, Rite Aid and Walmart, as well as online. The first batch of recalled eye drops from March caused eye infections in dozens of eye drop users and several cases of blindness; a handful of individuals required eyeball removal surgery and there were at least four associated deaths. Eye drops with preservatives. This type often comes in multidose bottles and contains preservatives that discourage growth of bacteria once the bottle has been opened. The preservatives may irritate your eyes, especially if you have moderate or severe dry eyes.If you use TheraTears Nighttime (carboxymethylcellulose) on a regular basis, use a missed dose as soon as you think about it. Refresh ® brand of artificial tears have several formulations containing 0.5% CMC alone, with additional demulcents and biologically active excipients like osmoprotectants erythritol, l-carnitine, and trehalose. L-carnitine and erythritol have been shown to attenuate hyperosmolar stress-mediated increase in MAP kinases, pro-inflammatory cytokines, and matrix metalloproteases in corneal epithelial cells [ 27, 28, 29, 30]. Clinical studies demonstrate that artificial tears containing L-carnitine and erythritol reduce tear osmolarity and provide symptomatic relief [ 31, 32, 33]. Studies in animal models of dry eye and clinical studies with trehalose containing eye drops demonstrate many beneficial effects, including increased tear production, tear stabilization, reduced corneal staining, and a decrease in corneal epithelial cell apoptosis [ 34, 35, 36, 37]. Humectant sodium hyaluronate in Refresh ®, Oasis ® and Blink ® tears can offer significant additional relief in dry eye in preventing or treating corneal epithelial damage since in vitro studies demonstrate that sodium hyaluronate promotes corneal epithelial cell migration and proliferation, thus facilitating healing [ 38, 39, 40]. Topical application of sodium hyaluronate in rabbits and mice has been shown to promote wound healing and relieve dry eye symptoms [ 41, 42]. Castor oils and flaxseed oil in some Refresh ® Brand tears will offer the additional benefit of reduced tear evaporation in patients with evaporative dry eye. Purite, the preservative present in Refresh ® brand artificial tears, is stabilized oxychloro complex (SOC) containing 99.5% chlorite, 0.5% chlorate. In solution, its bactericidal action is mediated by the oxidizing action of chlorine dioxide free radical. It belongs to the vanishing class of artificial tears since upon instillation, it is converted to sodium chloride, oxygen, and water [ 43, 44]. Animal studies demonstrate that purite is significantly less toxic to corneal epithelium compared to benzalkonium chloride but has some degree of detrimental effect compared to preservative-free artificial tears [ 43, 44, 45, 46, 47]. Given the wide variety of options, a patient can be started on Refresh ® tears with CMC alone either with or without preservatives depending upon the frequency of instillation required and if the dry eye relief is inadequate, Refresh ® tears with additional biologically active excipients can be tried.