The ingredient that will work best varies from person to person, so be ready for a little trial and error. 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. T]emporarily relieve minor symptoms such as: •dry eye •redness of eyes and lids •reflex watering secondary to dry eye” o A complete and final review of each batch and its related information before the QU disposition decision

T]emporarily relieve the symptoms of eye strain that may include blurred vision, hypersensitivity to light, and dry eyes” Uses: According to homeopathic principles, the medicinal ingredients in this medication temporarily relieve minor symptoms such as: • dryness Similasan eye drops soothe and provide temporary relief of the following symptoms: •Redness •Burning •Watery discharge •Sensation of Grittiness” Uses: Homeopathic remedy for use in temporarily relieving the minor symptoms associated with styes such as:• redness • tearing• painful swelling Similasan Complete Eye Relief is designed for temporary multi-symptom relief from redness, burning, watering, grittiness, dryness, and irritation”

More Natural Relief From Similasan

Supportive documentation clarifying whether you are conducting routine osmolarity testing for your topical ophthalmic drug products for release and stability testing. T]emporarily relieve minor eye symptoms such as: •itching •burning •redness of eyes and lids •stinging •excessive watering •irritation” 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.

You might think that more ingredients equals more kinds of relief, but that’s not necessarily the case. Many eye drops, especially those that reduce redness, include vasoconstrictors in the form of decongestants, and these aren’t safe for long-term use. T]emporarily relieve minor symptoms such as: •redness of the eyes •irritation, dryness, and burning •sensation of grittiness, stinging •excessive watering (clear)” Symptoms associated with bacterial eye infections can include a wide array of eye-related discomfort and pain, including yellow, green or clear discharge; redness of the eye or eyelid; increased light sensitivity; consistent blurry vision; as well as an unshakable inner-eye irritation that feels like an itch, according to CDC officials. And symptoms triggered by this particular bacterial infection may start presenting usually within 12 to 24 hours, per published research. 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.”Do not use: If the solution changes color or becomes cloudy or if the condition is accompanied by fever. 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 minor eye allergy symptoms such as: •itching •burning •excessive watering •redness of eyes and lids” 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.

o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices 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. Your laboratory records do not include complete testing data to support the analysis performed. For example, negative controls for sterility testing are not documented at the time of performance. The absence of concurrently performed negative controls during sterility testing does not allow full assessment of the suitability of the testing performed. 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. A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.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. 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. 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)).

Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this product has yet to be linked to any illnesses or injuries related to Pseudomonas aeruginosa. Its manufacturers have indicated that two lots of this product may not be sterile. These products, made in 1oz and .5oz sizes, can be identified using lot codes and UPC information. Implicated products display the following identifiers: LOT#: 2203PS01, UPC 7 31034 91379 9; and LOT#: 1808051, UPC 7 31034 91382 9. 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. Medicinal ingredients: Atropa bella-donna, Belladonna* (whole plant) 6X; Euphrasia officinalis 3c, Euphrasia 3c (whole fresh plant) 6X; Hydrargyrum bichloratum, Mercury (II) chloride 6XThere 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. Here's a full list of recalled eye drops and more context on why federal regulators have placed these on recall lists in the first place: