SIMILASAN EYE DROP RELIEF

Product Information

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 . Do not use: If the solution changes color or becomes cloudy or if the condition is accompanied by fever. Medicinal ingredients: Atropa bella-donna, Belladonna* (whole plant) 6X; Euphrasia officinalis 3c, Euphrasia 3c (whole fresh plant) 6X; Hydrargyrum bichloratum, Mercury (II) chloride 6X Similasan Aging Eye Relief eye drops are specially designed to support corneal and macular health, and […] provide temporary relief for dryness”

Similasan Complete Eye Relief is designed for temporary multi-symptom relief from redness, burning, watering, grittiness, dryness, and irritation” Uses: Homeopathic remedy for use in temporarily relieving the minor symptoms associated with styes such as:• redness • tearing• painful swelling 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. Similasan eye drops soothe and provide temporary relief of the following symptoms: •Redness •Burning •Watery discharge •Sensation of Grittiness”You manufacture multiple drugs that contain glycerin or sorbitol solution. Identity testing for these and certain other high-risk drug components 2 includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of diethylene glycol (DEG) or ethylene glycol (EG). 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. Read on to learn more about a current list of recalled eye drops and symptoms of bacterial eye infections to consider. This article will be updated with more information about current recalls as it becomes available. T]emporarily relieve minor symptoms such as: •dry eye •redness of eyes and lids •reflex watering secondary to dry eye”

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)).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. Your ophthalmic products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your ophthalmic products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. (21 CFR 211.194(a)) A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to: 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.

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. Anisocoria could suggest a life-threatening event due to its association with cranial third-nerve palsy or Horner’s syndrome. Pharmacological mydriasis is one of the benign etiologies of anisiocoria. Although it is common knowledge that the vasoconstrictor in over-the-counter (OTC) eye drops can cause adrenergic mydriasis, 1 there has never been a published report on the pupillary effect from OTC homeopathic eye drops. o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products

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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. Adequate procedures for that are designed to prevent microbiological contamination of drug products purporting to be sterile (21 CFR 211.113(b)). Most drops will require you to use them once or twice per day. You’ll get the same amount of medication over a 24-hour period, but one way may end up being more preferable to you than the other. 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.

Additional eye drop recalls are making headlines this month, but it's important to note that they are not expressly related to bacterial infections being linked to Pseudomonas aeruginosa. Read on to learn which eye drops are being recalled and why. o Personnel Flows and Material Flows (throughout all rooms used to conduct and support sterile operations)

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. 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.” T]emporarily relieve minor eye symptoms such as: •dry eye •redness of eyes and lids •reflex watering secondary to dry eye”