SIMILASAN EYE DROP RELIEF

Product Information

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. T]emporarily relieve minor symptoms such as: •aching eyes •burning •redness •strained eyes (Computer, TV, reading, driving)” Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).

o A complete and final review of each batch and its related information before the QU disposition decision T]emporarily relieve minor symptoms such as: •dry eye •redness of eyes and lids •reflex watering secondary to dry eye” 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.Adequate procedures for that are designed to prevent microbiological contamination of drug products purporting to be sterile (21 CFR 211.113(b)). 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.” Adequate procedures to establish laboratory controls that include scientifically sound and appropriate specifications, standards, and sampling plans sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

o Take prompt and appropriate actions for all batches of drug products that contain unacceptable levels of ingredients that could cause them to be harmful, including customer notifications and other applicable market actions for any batches containing harmful ingredients. Detail these actions in your response to this letter. 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. 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. During our inspection, our investigators observed specific violations including, but not limited to, the following: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. T]emporarily relieve minor eye symptoms: •excessive watery (clear) discharge •sensation of grittiness •redness and burning”

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)) Uses: Homeopathic remedy for use in temporarily relieving the minor symptoms associated with styes such as:• redness • tearing• painful swelling There are two main kinds of ingredients in eye drops that can reduce your allergic reaction to seasonal or environmental triggers: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. T]emporarily relieve the symptoms of eye strain that may include blurred vision, hypersensitivity to light, and dry eyes” Similasan Aging Eye Relief eye drops are specially designed to support corneal and macular health, and […] provide temporary relief for dryness”