SIMILASAN EYE DROP RELIEF

Product Information

T]emporarily relieve minor eye allergy symptoms such as: •itching •burning •excessive watering •redness of eyes and lids” 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. 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. Uses: Homeopathic remedy for use in temporarily relieving the minor symptoms associated with styes such as:• redness • tearing• painful swelling

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). FDA placed all products from your establishment in Switzerland on Import Alert 66-40 on July 24, 2023. 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 minor symptoms such as: •aching eyes •burning •redness •strained eyes (Computer, TV, reading, driving)” 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))

Key Ingredients

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: We presented an unusual anisocoria case, with pharmacological mydriasis lasting more than 2 weeks that was caused by use of Similasan Pink Eye Relief OTC homeopathic eye drops. Although the patient’s pupil started to respond to light and near stimuli one week after cessation of the drops, the anisocoria was not completely resolved one year after cessation of the drops. Fourteen people have been blinded and four have had their eyeballs surgically removed. The number of deaths linked to the outbreak has rise from three to four.

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. A: The recommended dose is 2-3 drops per eye as needed. Continue use until symptoms diminish. Similasan eye drops can then be used as often as needed. 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.”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))