How to tell if eye drops are counterfeit

Start with the package before you open anything. A genuine over-the-counter eye drop has an intact tamper seal, a complete Drug Facts panel in the FDA’s standard format, a printed lot number and expiration date, and contents that match the label. Misspellings, missing sections, a broken seal or drops that look wrong are reasons not to use the bottle. If you suspect a fake, keep it and report it to the FDA’s MedWatch program.

Check the tamper seal first

Eye drops are sealed so you can tell whether a bottle was opened after it left the maker. Before you twist anything, look closely:

• Is the seal there at all, and is it unbroken all the way around?
• Does it look like it was cut, peeled or glued back down?
• Is the cap sitting at an odd angle, or loose before you’ve turned it?
• Is the carton’s flap torn, re-taped or crushed in a way that looks deliberate?

A broken seal doesn’t prove a bottle is counterfeit, since damage happens in transit. Either way, don’t use it. A Quell order that arrives with a broken tamper seal is replaced; what if the tamper seal is broken explains how to report it.

Read the Drug Facts panel

Federal rules at 21 CFR 201.66 set the format for the Drug Facts panel on over-the-counter drugs: the title “Drug Facts,” then Active ingredient(s), Purpose(s), Use(s), Warnings, Directions, Other information and Inactive ingredients, in that order, often followed by Questions. Counterfeiters tend to get this part wrong. Signs worth noticing:

• Sections missing, out of order, or with headings that don’t match the standard ones.
• Misspelled ingredient names or company names.
• Blurry, pixelated printing, or text that looks photocopied.
• Directions or warnings that differ from the same product you bought before.
• No company name and address on the package.

For Quell, you can compare the carton line by line with the transcription on the Drug Facts page. The active ingredients are Glycerol (1.0%), Polysorbate 80 (1.0%) and Light Mineral Oil (0.5%). The inactive ingredients are Caprylyl Glycol, Dead Sea Salt (Sodium Chloride), Emu Oil, Glyceryl Laurate, Glyceryl Undecylenate, Manuka Honey, Polaxamer 188, Sterile Water, Terminalia Chubula and Tromethamine. The directions read: Apply 1 drop 3 times per day in each eye. If the carton you’re holding says something different, stop and call before using it.

Look for the lot number, expiration date and NDC

Legitimate drug packaging carries a lot number and an expiration date, usually stamped together on a carton flap, the bottom of the box or the bottle itself. Smudged, scratched-off or missing codes are a warning sign. Many drug cartons also print a National Drug Code, the number that identifies the product and package; what is the NDC number on eye drops explains where it appears and what it does and doesn’t tell you.

Compare the codes on the carton with those on the bottle. They should match. A carton and bottle with different lot numbers suggest the two didn’t start out together. What the lot number on eye drops means covers how batches are tracked.

Check what the drops themselves look like

Many eye drops are clear, so people assume all of them should be. Quell isn’t. Its label states: Product appears as a milky brown solution. The site’s own note says: The eye drops have a naturally milky-brown appearance. This is normal and does not indicate a problem with the product. A clear, watery liquid in a Quell bottle would be the thing to question.

The label also says If this product changes color. If the color has shifted from how it looked when you first opened it, or the liquid has particles floating in it, set the bottle aside. How do I know if my eye drops have gone bad covers the other signs.

Where the bottle came from matters

Most counterfeit risk comes from the seller, not the shelf. Bottles from marketplace listings with unclear sellers, social media ads, flea markets or overseas sites are harder to trace back to the maker. A price far below what you usually pay is a reason to slow down. How to spot a fake eye drop website covers checking an online shop before you buy, and where can I buy Quell lists where Quell comes from.

Orders from quelldrop.com ship from Brentwood, Tennessee. If anything about a Quell package looks off, call 615.465.6041, M–F 9AM–5PM CST, before you use it.

How to report a suspected counterfeit

The FDA’s MedWatch program accepts reports from consumers about suspected counterfeit medical products. You can report online, on the consumer form FDA 3500B, or by phone at 1-800-FDA-1088. The FDA notes that photos of all sides of the product help it review a report.

• Don’t throw the bottle or the carton away.
• Photograph every side of the carton and bottle, including the seal and the printed codes.
• Note where and when you bought it, and keep the receipt or order confirmation.
• If you used the drops and your eyes hurt or your vision changed, see a doctor first, then report.