SIMILASAN EYE DROP RELIEF

Product Information

T]emporarily relieve minor eye symptoms such as: •excessive watery (clear) discharge •sensation of grittiness •redness and burning” It's okay to use these drops rarely if you need to—however they will not provide long-term allergy relief [and can also] create rebound redness,” explains Dr. Dass. Update (10/30/23): The Food and Drug Administration (FDA) is warning consumers to immediately stop using and discard 26 different eye drops products, including several that are sold at retailers like CVS, Target and Rite Aid. The FDA urges eye drops users to stop using and purchasing over-the-counter eye drops marketed under the following brands (and also properly dispose of any of the potentially affected products): Update (5/19/23): The Centers for Disease Control and Prevention (CDC) has issued an update about the outbreak of Pseudomonas aeruginosa bacteria associated with the use of artificial tears. As of May 15, 81 patients (up from 68 in March) have been infected with with VIM-GES-CRPA, a rare strain of drug-resistant bacteria . T]emporarily relieve the symptoms of eye strain that may include blurred vision, hypersensitivity to light, and dry eyes”

Update (8/25/23): The FDA is urging consumers to immediately stop using two brands of eye drops sold online — Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops-Eye Repair — due to bacterial and/or fungal contamination. What’s more: These eye drops were also found to contain the active ingredient methylsulfonylmethane (MSM), which is not approved for use in any legally marketed eye-related drugs or products in the U.S., says the FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. It is challenging for ophthalmologists to understand the mechanisms and side effects of homeopathic OTC eye drops since most times there are no active chemical ingredients available, and the drug fact sheet lists only the names of the natural (botanical) source, which are most likely unfamiliar to most practitioners. Two of the nine types of Similasan eye drops, complete eye relief and irritated eye relief (previously called pink eye relief), contain belladonna, which can lead to pupil dilation, complicating the decision-making process during the work-up for anisocoria and the management of angle closure glaucoma. We believe it would be safer for patients/consumers if the manufacturers were required to, at the very least, list pupil dilation as a side effect and to include warnings such as “do not use if you have narrow angle glaucoma.” A: The recommended dose is 2-3 drops per eye as needed. Continue use until symptoms diminish. Similasan eye drops can then be used as often as needed. Symptoms associated with bacterial eye infections can include a wide array of eye-related discomfort and pain, including yellow, green or clear discharge; redness of the eye or eyelid; increased light sensitivity; consistent blurry vision; as well as an unshakable inner-eye irritation that feels like an itch, according to CDC officials. And symptoms triggered by this particular bacterial infection may start presenting usually within 12 to 24 hours, per published research.

Suggested Usage

But CDC officials have also indicated they are still actively investigating the source of bacterial contamination — there's a possibility that more recalls may take place in the future as healthcare providers learn more about those impacted by tainted eye drops. "Patients reported over 10 different brands of artificial tears and some patients used multiple brands," the CDC indicated. Most drops will require you to use them once or twice per day. You’ll get the same amount of medication over a 24-hour period, but one way may end up being more preferable to you than the other.

You failed to establish and conduct 100% visual inspections of your ophthalmic drug products to ensure that each container is essentially free of visible particulates. Since at least June 23, 2022, your established in-process inspection procedure for in-process inspection for visible particulates was limited to acceptable-quality-limits (AQLs). The use of AQL sampling is intended as an additional analysis routinely conducted as part of the quality release processes only after performing 100% visual inspection. Your failure to conduct 100% visual inspection increases the risk for the release of ophthalmic drug product with visible particulate contamination. You manufacture multiple drugs that contain glycerin or sorbitol solution. Identity testing for these and certain other high-risk drug components 2 includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of diethylene glycol (DEG) or ethylene glycol (EG). The Purpose of this product is to provide temporary relief of stye symptoms, and is not a cure for styes. T]emporarily relieve minor symptoms such as: •redness of the eyes •irritation, dryness, and burning •sensation of grittiness, stinging •excessive watering (clear)” Uses: According to homeopathic principles, the medicinal ingredients in this medication temporarily relieve minor symptoms such as: • drynessWhen selecting the best eye drops for allergies, we researched dozens of top brands and formulations. We also spoke to allergists and an ophthalmologist to find out what patients should look for in an over-the-counter solution to eye allergy irritation. These experts include: Stop use and ask a doctor if: Symptoms worsen or persist for more than 72 hours, changes in vision occur or you experience eye pain. Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this product has yet to be linked to any illnesses or injuries related to Pseudomonas aeruginosa. Its manufacturers have indicated that two lots of this product may not be sterile. These products, made in 1oz and .5oz sizes, can be identified using lot codes and UPC information. Implicated products display the following identifiers: LOT#: 2203PS01, UPC 7 31034 91379 9; and LOT#: 1808051, UPC 7 31034 91382 9. There are two main kinds of ingredients in eye drops that can reduce your allergic reaction to seasonal or environmental triggers:

FDA placed all products from your establishment in Switzerland on Import Alert 66-40 on July 24, 2023. Your inadequate media fill studies compromise your ability to accurately assess the state of validation and process control. To ensure a valid assessment, it is critical that media fill studies accurately simulate the number and type of interventions that occur during commercial manufacturing. b)(4), batch (b)(4), documented 38 interventions in the cap (b)(4) area during manufacture and 14 interventions were simulated during your supportive media fill Similasan Aging Eye Relief eye drops are specially designed to support corneal and macular health, and […] provide temporary relief for dryness”On examination, her vision was 20/25 for each eye. Her right pupil was 3 mm and 5 mm under bright and dim light, respectively; however, her left pupil remained at 7.5 mm with no constriction to light or near stimulation. There was no left relative afferent pupil defect by reverse, no left ptosis, nor extraocular movement abnormality. Intraocular pressure, anterior segment, and posterior segment were unremarkable, except for mild nucleus sclerosis bilaterally and left choroidal nevus. Upon investigation, it was found that the OTC Similasan Pink Eye Relief drops, which the patient had used, contained the following active ingredients: Belladonna 6X, Euphrasia 6X, and Hepar sulphuris 12X.