SIMILASAN EYE DROP RELIEF

Product Information

Do not use: If the solution changes color or becomes cloudy or if the condition is accompanied by fever. T]emporarily relieve minor eye symptoms: •excessive watery (clear) discharge •sensation of grittiness •redness and burning”

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.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. The ingredient that will work best varies from person to person, so be ready for a little trial and error.

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 . 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. Your unapproved ophthalmic drug products are especially concerning from a public health perspective, particularly given your firm’s significant violations of CGMP regulations. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses. 1 o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsYour 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)) 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. 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: Uses: According to homeopathic principles, the medicinal ingredients in this medication temporarily relieve minor symptoms such as: • dryness 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.

T]emporarily relieve the symptoms of eye strain that may include blurred vision, hypersensitivity to light, and dry eyes” 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.

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Adequate procedures for that are designed to prevent microbiological contamination of drug products purporting to be sterile (21 CFR 211.113(b)). Similasan Complete Eye Relief is designed for temporary multi-symptom relief from redness, burning, watering, grittiness, dryness, and irritation” When 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.