Preservative-free eye drops are popular because people believe they are safer.

But some companies are putting preservative-free eye drops in bottles designed only for preserved eye drops. These bottles can draw bacteria into the bottle after every squeeze. In addition, many of these improperly packaged eye drops contain ingredients which can act as a food source for the bacteria.

Pictorial guide to safe eye drop packaging

Video about Frankenstein bottles

CDC issued an emergency HAN alert on February 1, 2023 about a multi-state outbreak of extensively drug-resistant Pseudomonas infections linked to an over-the-counter eye drop called Ezricare Artificial Tears. FDA has since announced a nationwide recall of Ezricare and Delsam Pharma artificial tears, both made at the same manufacturing facility.

Patient outcomes include permanent vision loss, hospitalization, and death of one patient.

According to federal law, eye drops marketed for any medical indication are drugs, and are regulated accordingly.

But several companies are formulating, packaging and selling eye drops as if they were vitamins - or energy drinks - or anything other than a drug.

These eye drops are not listed in the OTC drug database. And, often, basic information required by law is not provided in the products’ labeling.

Specialists around the country are “prescribing” costly eye drops that the FDA has declared to be unapproved biologic drugs with no evidence of safety or purity.

The manufacturers of these eye drops have not conducted any clinical trials at all - although clinical trials are required before these eye drops can legally be sold.

One manufacturer of such a “biologic” drop, in an attempt to deflect critics, has successfully created the appearance of legitimacy by manipulating a loophole in the FDA’s OTC drug listing software to obtain a National Drug Code (NDC) and get listed in the National Library of Medicine as an OTC drug.

FDA regulation of over-the-counter eye drops works on an “honor system” basis.

While in the past this seemed adequate for large corporate manufacturers, today, an increasing number of small businesses are manipulating the system, declaring it irrelevant, or simply ignoring it.

And they are doing so with impunity.

The nature and variety of safety violations are such that consumers now have NO thoroughly reliable means of distinguishing between products that are following safety rules and products that are not.