SIMILASAN EYE DROP RELIEF

Product Information

Fourteen people have been blinded and four have had their eyeballs surgically removed. The number of deaths linked to the outbreak has rise from three to four. We note that your ophthalmic drug products utilize silver sulfate as a preservative. The Agency has significant concerns regarding the safety of silver sulfate for use as an ophthalmic preservative. Long term use of medicinal compounds containing silver may cause argyria, which is a blueish-gray discoloration of the skin and eyes that is irreversible. Additionally, granular deposits of silver in the conjunctiva and cornea may cause decreased night vision. Accordingly, we are concerned that your use of silver sulfate as a preservative in your ophthalmic products is inconsistent with 21 C.F.R. 200.50(b)(1), under which ophthalmic preservatives should be “suitable and harmless.” FDA relayed our concerns regarding this issue with you on July 14, 2023. Your laboratory records do not include complete testing data to support the analysis performed. For example, negative controls for sterility testing are not documented at the time of performance. The absence of concurrently performed negative controls during sterility testing does not allow full assessment of the suitability of the testing performed. 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 .

During our inspection, our investigators observed specific violations including, but not limited to, the following: The ingredient that will work best varies from person to person, so be ready for a little trial and error. Stop use and ask a doctor if: Symptoms worsen or persist for more than 72 hours, changes in vision occur, you experience eye pain, the stye enlarges, or the stye opens, draining discharge or pus into the eye.This warning letter also summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). There are two main kinds of ingredients in eye drops that can reduce your allergic reaction to seasonal or environmental triggers: Here's a full list of recalled eye drops and more context on why federal regulators have placed these on recall lists in the first place:

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.

Ingredients

Because eye drops often focus on relieving a single symptom of allergies, you’ll have to experiment a little when it comes to finding a product that works for you. If you only have one symptom, like dryness, you don’t need a multi-action drop. On the other hand, if your eyes are itchy, red, and watery, that might be your best bet. 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.”

As with any other medication, you can’t properly treat your symptoms if you don’t know what they are. Dr. Dass says it's important to confirm that you’re definitely dealing with eye allergies, not a similar problem like dry eyes or blepharitis (also called granulated eyelids), since those conditions are treated differently. Eye redness and grittiness can also be symptomatic of viral conjunctivitis or pink eye, in which case getting an accurate temperature reading would aid in diagnosis and treatment. You may need to meet with an allergist to hone in on your individual symptoms and, preferably, figure out your triggers; while eye drops can treat symptoms, the only way to prevent symptoms entirely is to avoid your triggers. If you have tried an antihistamine eye drop and not found relief, you may find relief with a mast cell stabilizer,” says Dr. Dass. “In rare circumstances, we use both to treat because they work differently.” A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation. 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). o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsT]emporarily relieve minor symptoms such as: •redness of the eyes •irritation, dryness, and burning •sensation of grittiness, stinging •excessive watering (clear)”

Given that your container closure system uses an (b)(4) vial, provide data supporting that your (b)(4) particle inspection system can adequately detect particles within your container closure. Delsam Pharma Artificial Eye Ointment: Produced by the same manufacturer, Delsam's topical ointment hasn't been linked to current cases as recorded by the CDC, but is being recalled due to "possible microbial contamination." While it's not technically an eye drop product, implicated tubes of ointment (which is used on skin in proximity to the eye) can be identified with the NDC 72570-122-35 and UPC code 3 72570 12235 3. 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. b)(4), batch (b)(4), documented 40 interventions in the cap (b)(4) area during manufacture and 23 interventions were simulated during your supportive media fill Medicinal ingredients: Atropa bella-donna, Belladonna* (whole plant) 6X; Euphrasia officinalis 3c, Euphrasia 3c (whole fresh plant) 6X; Hydrargyrum bichloratum, Mercury (II) chloride 6XAnyone experiencing symptoms and who have used either of the two branded eye drops recently should seek immediate emergency medical care. Severe eye infections may often go ignored or misdiagnosed without clinical care, and left untreated, could cause life-threatening complications, especially with drug-resistant strains of bacteria like the one being traced by CDC officials.