SIMILASAN EYE DROP RELIEF

Product Information

Free from oxybenzone, phthalates, parabens, nano particles, triclosan, synthetic fragrances and animal testing. Suitable for vegans. Ingredients derived from palm oil are from RSPO certified sources. The written procedures for your media fills were not appropriate because they failed to accurately simulate commercial manufacturing. Our inspection found that aseptic interventions simulated during your media fills were not sufficiently representative of commercial aseptic manufacturing. For example, the number of interventions conducted during your manually intensive commercial operations exceeded the number performed during your media fills as follows, Similasan Complete Eye Relief is designed for temporary multi-symptom relief from redness, burning, watering, grittiness, dryness, and irritation” 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 .

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 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. T]emporarily relieve the symptoms of eye strain that may include blurred vision, hypersensitivity to light, and dry eyes” 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.Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. (21 CFR 211.160(b)) Chamomilla or chamomile is found in Europe, Asia, America and Australia and is, since acient times, used for its healing qualities, anti-septic properties and pleasant smell. In the homeopathic literature, chamomile is known for its calming properties, such as fatigue and hypersensitivity of the nervous system. The mere mention of OTC eye drops probably makes you think of Visine. The company has been doing eye care for decades, and they offer several different formulations of drops designed to help with literally any eye problem you could possibly have (yes, even eye strain from too much screen time).

T]emporarily relieve minor eye symptoms such as: •dry eye •redness of eyes and lids •reflex watering secondary to dry eye” 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. Stye Eye Relief Temporary relief of symptoms associated with styes such as redness, burning, & tearing 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.Your response is inadequate. There is no commitment to conduct a retrospective review for your released drug products that only relied on the AQL sampling to try and assure product quality and limit patient risk. Additionally, your response did not include supportive documentation for routine osmolarity testing of your ophthalmic drug products. Similasan Aging Eye Relief eye drops are specially designed to support corneal and macular health, and […] provide temporary relief for dryness”

Similasan eye drops soothe and provide temporary relief of the following symptoms: •Redness •Burning •Watery discharge •Sensation of Grittiness” T]emporarily relieve minor symptoms such as: •aching eyes •burning •redness •strained eyes (Computer, TV, reading, driving)”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. 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: Similasan Complete Eye Relief Sterile Eye Drops provide homeopathic support for multi-symptom relief of redness, watering, dryness, burning, grittiness and irritation. Many other eye drops have vasoconstrictors or harsh chemicals that may actually worsen symptoms if used more than directed. Complete Eye Relief works in harmony with your body to boost your natural defenses, so you can feel good about using it. Witch-hazel has an astringent, haemostatic and anti-inflammatory effect. Experts attribute this effect to the relatively high tannin content.

If you are pregnant or nursing, please consult your healthcare professional before using this product.While recalls are being implemented across the nation, cases thus far have been recorded in 16 states: California, Colorado, Connecticut, Florida, Illinois, Nevada, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, South Dakota, Texas, Utah, Washington and Wisconsin.