SIMILASAN EYE DROP RELIEF

Product Information

Designed for temporary multi-symptom relief from redness, burning, watering, grittiness, dryness, and irritation. If eye redness is your biggest problem, you’ll probably have to choose drops that contain a decongestant like naphazoline. This ingredient acts as a vasoconstrictor, meaning it shrinks the inflamed blood vessels so they become less noticeable. During our inspection, our investigators observed specific violations including, but not limited to, the following: T]emporarily relieve minor symptoms such as: •redness of the eyes •irritation, dryness, and burning •sensation of grittiness, stinging •excessive watering (clear)” T]emporarily relieve minor eye symptoms: •excessive watery (clear) discharge •sensation of grittiness •redness and burning”

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 Stye Eye Relief Temporary relief of symptoms associated with styes such as redness, burning, & tearing Calendula officinalis, or marigold, is a medicinal plant which grows in the sunny regions of Southern Europe and Asia. In the homeopathic literature Calendula is known for its antiseptic and anti-inflammatory properties. It acts as a soothing agent because it relaxes the nerves. Additionally the Marigold flower has a healing effect on the skin. The FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after " agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility." Eye drops are intended to be sterile, especially due to a heightened risk for infection since they bypass some of the body's natural defenses by being applied directly into the eyes.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. We recognize that your ophthalmic products are labeled as homeopathic drugs with active ingredient(s) measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval. 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. The Purpose of this product is to provide temporary relief of stye symptoms, and is not a cure for styes. Healthcare providers at the University of California, Davis's Eye Center published materials that suggest that this particular bacteria impacts the eye by destroying the cornea specifically. While this specific strain of bacteria has not been linked to eye drops previously, CDC officials noted that P. aeruginosa caused upwards of 2,700 deaths in 2017 specifically. Historically, it has caused infections through sepsis (in the blood) or respiratory and urinary tract infections, with upwards of 33,000 recorded cases in the same year.

If the eye drops contain certain ingredients, you can develop a dependency. The main ingredient to be extremely mindful of is Naphazoline HCI; this is a decongestant ingredient which shrinks the blood vessels in your eye to make them appear less visibly red, but it will cause a rebound effect if used too often. o Personnel Flows and Material Flows (throughout all rooms used to conduct and support sterile operations) Similasan has been developing eye drops for specific conditions for the last 40 years. Always with high Swiss quality and made from 100% natural ingredients. Similasan Stye Eye Drops have a pH value that matches that of your own tears. The unique composition consists of Euphrasia officinalis and Hamamelis virginiana. 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.Aqua (water), pongamia glabra seed oil, dicaprylyl ether, zinc oxide, caprylic/capric triglyceride, polyglyceryl-3 polyricinoleate, glycerin, alcohol*, olea europaea fruit oil, titanium dioxide, oryza sativa bran oil, linum usitatissimum oil*, tocopherol, alumina, stearic acid, pongamol, helianthus annuus seed oil*, simmondsia chinensis oil*, argania spinosa kernel oil*, hydrated silica, oryzanol, magnesium stearate, calendula officinalis flower extract*, malva sylvestris leaf extract*, bisabolol, magnesium sulphate eptahydrate, stearic acid. 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. Do not use: If the solution changes color or becomes cloudy or if the condition is accompanied by fever. Those drops should not be used more than just every so often for a special occasion or picture,” explains Dr. Rapoport. Uses: Homeopathic remedy for use in temporarily relieving the minor symptoms associated with styes such as:• redness • tearing• painful swelling

Is starts with tenderness and redness around the eye-the beginnings of a stye. Now you have a way to soothe the discomfort. Similasan Stye Eye Relief sterile eye drops stimulate the body’s natural ability to temporarily relieve symptoms of styes, such as redness, burning, dryness, and tearing. Your response states that you plan to include these and other interventions in the next media fill simulation, scheduled for June 2023. Your response failed to include a risk assessment or investigation to determine whether the safety of your drug products are impacted by the excessive manual interventions during aseptic operations. Our Original Swiss Formulas are made with 100% Natural Active Ingredients, add for over 30 years have been providing families with remedies they can trust. Supportive documentation clarifying whether you are conducting routine osmolarity testing for your topical ophthalmic drug products for release and stability testing.Similasan Complete Eye Relief is designed for temporary multi-symptom relief from redness, burning, watering, grittiness, dryness, and irritation” Medicinal ingredients: Atropa bella-donna, Belladonna* (whole plant) 6X; Euphrasia officinalis 3c, Euphrasia 3c (whole fresh plant) 6X; Hydrargyrum bichloratum, Mercury (II) chloride 6X For all batches that you have not conducted 100% visual inspection, conduct 100% visible inspection of your retain samples. If you obtain out-of-specification (OOS) results, conduct investigations and provide your completed investigations, including conclusions and take appropriate market action for all batches of drug products confirmed not meeting specifications. Comprehensive risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including an independent assessment that includes, but is not limited to: Adequate procedures for that are designed to prevent microbiological contamination of drug products purporting to be sterile (21 CFR 211.113(b)).

There are a few other eye drops and one other eye ointment that have been concurrently recalled in the same period as the two products above — but not due to the same potential bacterial exposure. We're recapping that information below. 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.

These eye drops are easy to use, and you can use these drops up to four times per day as needed, but not for more than 72 hours in a row. These drops contain a decongestant which you could become dependent on if you use them consistently. Eye allergies that are seasonal or require longer symptom relief should be treated with a product that doesn’t contain any decongestant. o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products