SIMILASAN EYE DROP RELIEF

Product Information

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)). 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. 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.” 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:

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. 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.There are two main kinds of ingredients in eye drops that can reduce your allergic reaction to seasonal or environmental triggers: 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. Anyone 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. Uses: According to homeopathic principles, the medicinal ingredients in this medication temporarily relieve minor symptoms such as: • dryness

During our inspection, our investigators observed specific violations including, but not limited to, the following: 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 The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products and at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. T]emporarily relieve minor eye allergy symptoms such as: •itching •burning •excessive watering •redness of eyes and lids”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. Do not use: If the solution changes color or becomes cloudy or if the condition is accompanied by fever. 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.

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.Your inadequate media fill studies compromise your ability to accurately assess the state of validation and process control. To ensure a valid assessment, it is critical that media fill studies accurately simulate the number and type of interventions that occur during commercial manufacturing.

Improved in-process testing and monitoring to enhance detection of variation during production of each batch. Include remediated in-process quality standards, including but not limited to enhanced sampling, that will more robustly monitor (b)(4) process control. Describe how the improvements will ensure early detection of process variation and manufacturing defects, and prevent consumer exposure to substandard quality drug products.

It's okay to use these drops rarely if you need to—however they will not provide long-term allergy relief [and can also] create rebound redness,” explains Dr. Dass.