The following definitions explain the basis upon which Dry Eye Foundation assigns Eye Drop Safety Alerts to products in the “Are my eye drops safe?” database. These alerts pertain to eye drops sold in the United States. Eye drops that are manufactured for sale in other countries may appear in this database if Dry Eye Foundation becomes aware that they are being illegally imported for sale in the U.S.
This flag is utilized when the product has none of the yellow or red safety flags as described below.
This flag is utilized when the FDA has published on its domain (www.fda.gov) a Company Announcement stating that one or more lots of the product are being recalled.
This flag is utilized when the FDA has published on its domain (www.fda.gov) a recommendation to consumers not to use this specific product. These recommendations may occur as drug alerts, public safety notifications, or press releases.
This flag is utilized when the FDA has published on its domain (www.fda.gov) a Public Safety Notification or other similar communication about the product class to which the product belongs, but does not explicitly warn consumers not to use this specific product.
This flag is utilized when the FDA has published a Warning Letter which was sent to the product’s distributor or manufacturer and which specifically references the product. Warning Letters are issued when there are significant and / or sustained violations of the Food, Drug & Cosmetic Act. These violations may pertain to drug marketing; drug ingredients; manufacturing quality; or more than one of these.
See: FDA Warning Letter database.
This flag is utilized when the FDA has published an Untitled Letter which was sent to the product’s distributor or manufacturer and this letter specifically references the product. Untitled Letters are not always published. If a product is referenced in a publicly available Untitled Letter, a link to the letter has been added to the product details.
This flag is utilized for a product when (1) its distributor is the recipient of a Warning Letter or an Untitled Letter in which the product is specifically listed, and a statement is made about unresolved manufacturing quality concerns, (2) its manufacturer is the recipient of a Warning Letter or Untitled Letter in which the product is specifically listed, or (3) the product is specifically listed in an FDA press release or Public Safety Notification in which manufacturing quality violations such as insanitary conditions are the reason for the consumer warning.
See: FDA Warning Letter database.
This flag is utilized for a product when the FDA has published on its Inspection Dashboard a completed inspection of the product’s manufacturing facility and the inspection has been classified as “Official Action Indicated (OAI)”.
This flag is utilized when the product is packaged in a standard multi-dose bottle (determined by inspecting photographs or purchasing the product) and it is labeled or marketed as preservative-free.
See: 21 CFR 200.50(b)
Learn more about Frankenstein Eye Drops
This flag is utilized when the product is packaged in a standard multi-dose bottle (determined by inspecting photographs or purchasing the product), its ingredient list does not contain an ingredient customarily utilized as an ophthalmic preservative in prescription eye drops, and no information is provided that demonstrates the efficacy of the ingredient identified as a preservative (if any) for the product.
See: 21 CFR 200.50(b)
Learn more about Frankenstein Eye Drops
This flag is utilized when (1) the distributor or manufacturer is the recipient of a Warning Letter identifying the product as an unapproved new drug, (2) the product contains in its active ingredient list an ingredient not expressly allowed in the Ophthalmic OTC Monograph, or (3) therapeutic claims are made for an ingredient which is not listed in the Ophthalmic OTC Monograph.
This flag is utilized when the distributor or manufacturer (1) has received a Warning Letter which lists unproven drug claims specific to the product, or (2) claims therapeutic benefit(s) for the product which are beyond those allowed by law for OTC ophthalmic products.
This flag is utilized when the product does not have an active registration on DailyMed, the National Institute of Health’s lookup tool for drugs registered with the FDA. All drugs manufactured, prepared, propagated, compounded, or processed for U.S. commercial distribution must be registered with the FDA.
See: 510(j)(1) of the FD&C Act, 21 U.S.C. 360(j)(1), and 21 CFR 207.41.
This flag is utilized when there are multiple verified reports of visible adulteration of the product, such as congealment, precipitation, discoloration or particulate matter.
See: 21 USC 351 (b)
A green flag indicates that the product listing has been updated within the last 30 days.
A light blue flag indicates that the product is a private label (e.g. drugstore brand) product stating “Similar to”, “Compare to” or “Compare active ingredient to followed by the name of a major national brand product.
A blue flag indicates that the product is no longer available for sale commercially.