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Regener-Eyes Recall
Regener-Eyes Recall

Regener-Eyes LLC unofficially announced that it was recalling its preservative-free eye drops packaged in a standard bottle without a multi-dose preservative free (MDPF) dropper. Due to the informal nature of the recall, customary recall information that patients need to ensure their own safety was not provided: product names, manufacture dates, lot numbers, expiration dates, and photographs that help identify improperly packaged eye drops.  

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Open Letter to Key Opinion Leaders
Open Letter to Key Opinion Leaders

DEF calls on Key Opinion Leaders to partner with the FDA for patient safety.

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What you need to know about eye color changing eye drops
What you need to know about eye color changing eye drops

Learn more about safety hazards of trending eye drop scams

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Safety Alert: Do Not Use Aqua Naina Sterile Saline Solution
Safety Alert: Do Not Use Aqua Naina Sterile Saline Solution

The Dry Eye Foundation is warning consumers against using Aqua Naina Sterile Saline Solution with any contact lenses, including scleral lenses.

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The FDA Drug Label
Education
The FDA Drug Label
Education

What goes into the Drug Facts label on your OTC drops? What claims are manufacturers allowed to make about OTC eye drops, and which ingredients can they use?

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Education
FDA Warning: South Moon, Rebright, FivFivGo copycat eye drops contaminated
News
FDA Warning: South Moon, Rebright, FivFivGo copycat eye drops contaminated
News

FDA identifies risks to consumers from copycat eye drops sold on marketplaces like Walmart.com. Learn about DEF’s history of concerns with these products and how you can stay safe.

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News
Regener-Eyes Manufacturer Cited by FDA For Objectionable Conditions and Practices
News
Regener-Eyes Manufacturer Cited by FDA For Objectionable Conditions and Practices
News

The manufacturer of Regener-Eyes underwent an FDA drug facility inspection for the first time this year. FDA’s report includes extensive citations for violations, including releasing products for commercial distribution despite failed tests.

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News
Associated Press: After recalls and infections, experts say safer eyedrops will require new FDA powers
National Press Coverage
Associated Press: After recalls and infections, experts say safer eyedrops will require new FDA powers
National Press Coverage

Dry Eye Foundation Medical Advisor Dr. Sandra Brown comments on proposed legislation to allow the FDA to perform premarket inspections for OTC eye drop manufacturing facilities.

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National Press Coverage
MedPage Today: What to Know About Ongoing Eye Drop Recalls
National Press Coverage
MedPage Today: What to Know About Ongoing Eye Drop Recalls
National Press Coverage

Coverage of the FDA’s enforcement actions concerning unsafe eye drops this year with quotes from Rebecca and Dr. Brown.

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National Press Coverage
“Toilet Testing”
Education
“Toilet Testing”
Education

DrB explains her voyage through the laws, rules, regulations, policies, and ‘we always do it this ways’ of pharmaceutical manufacturing to explain why rigorous sterility testing of eye drops is so essential to our safety and how we can avoid high risk eye drops.

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Education
New York Post: Tainted eyedrops pulled by CVS, Target made by barefoot workers in India: report
National Press Coverage
New York Post: Tainted eyedrops pulled by CVS, Target made by barefoot workers in India: report
National Press Coverage

New York Post covers Killitch recall and references DEF’s history of eye drop safety warnings to the public.

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National Press Coverage
Bloomberg: “Tainted Walmart, CVS Eyedrops Tied to Unsanitary Indian Factory”
National Press Coverage
Bloomberg: “Tainted Walmart, CVS Eyedrops Tied to Unsanitary Indian Factory”
National Press Coverage

“Eyedrops pulled from pharmacy shelves around the US last month were made in an unsanitary factory in India where workers went barefoot and made up test results so the products appeared to be safe, according to a US government report.”

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National Press Coverage
Vision Monday: The Optical Community Weighs In on the Latest FDA Eye Drop Warning
National Press Coverage
Vision Monday: The Optical Community Weighs In on the Latest FDA Eye Drop Warning
National Press Coverage

Vision Monday links to “Are My Eye Drops Safe” in coverage on latest FDA eye drop warning

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National Press Coverage
Popsugar: Are Eye Drops Still Safe to Use? Here's What the Latest FDA Recall Means
National Press Coverage
Popsugar: Are Eye Drops Still Safe to Use? Here's What the Latest FDA Recall Means
National Press Coverage

Popsugar interviews 3 eye doctors, including Dr. Brown, about recent eye drop recalls and how to keep safe.

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National Press Coverage
Optometry Times: FDA waves red flag over eye drops for potential risk of eye infection
National Press Coverage
Optometry Times: FDA waves red flag over eye drops for potential risk of eye infection
National Press Coverage

Optometry Times references DEF’s biologic eye drop campaign in 2022 and history of publishing eye drop safety alerts in 2023.

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National Press Coverage
Evolving Situation: Velocity Pharma Eye Drop Warnings & Recalls
Evolving Situation: Velocity Pharma Eye Drop Warnings & Recalls

Latest information on warnings and recalls of Velocity Pharma eye drops sold under brands CVS, Leader, Rugby, Rite Aid, Target Up & Up, Walmart Equate and Velocity Pharma.

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Vision Monday: Dry Eye Foundation Introduces New Eye Drop Lookup Tool
National Press Coverage
Vision Monday: Dry Eye Foundation Introduces New Eye Drop Lookup Tool
National Press Coverage

Vison Monday covers DEF’s new OTC eye drop lookup tool

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National Press Coverage
Infographic: Are My Eye Drops Safe?
Resource
Infographic: Are My Eye Drops Safe?
Resource

Infographic about “Are My Eye Drops Safe?” with QR code for quick access to database

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Resource
Dry Eye Foundation Launches New Eye Drop Lookup Tool
DEF Press Release
Dry Eye Foundation Launches New Eye Drop Lookup Tool
DEF Press Release

Nonprofit introduces comprehensive database of over-the-counter eye drop in response to escalating safety issues and eroding consumer confidence.

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DEF Press Release
What’s Going On With the FDA & Homeopathic Eye Drops?
Education
What’s Going On With the FDA & Homeopathic Eye Drops?
Education

On Tuesday, September 12, the FDA issued a news release about several new warning letters to manufacturers of over-the-counter eye drops deemed to be illegally marketed.

Dr. Brown discusses the content of the letters and their implications.

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Education
K.C. Pharmaceuticals, Inc.
News, Education
K.C. Pharmaceuticals, Inc.
News, Education

Dr. Brown’s commentary on a Warning Letter sent by the FDA to K.C. Pharmaceuticals, a large manufacturer of private-label eye drops sold in the US.

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News, Education
Safety-Related Recalls and Warnings for OTC Eye Drops are Escalating
News
Safety-Related Recalls and Warnings for OTC Eye Drops are Escalating
News

Six months, seven manufacturers, eleven products: It’s been an unprecedented year for eye drop recalls and FDA warnings.

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News
Survey: Eye Drops Sold Online Pose Risks to Consumers
National Press Coverage
Survey: Eye Drops Sold Online Pose Risks to Consumers
National Press Coverage

Extensive coverage from Drugwatch detailing DEF’s history of reporting potentially unsafe eye drops to the FDA.

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National Press Coverage
Dry Eye Foundation Applauds Breakthrough Investigation of OTC Eye Drop Safety Issues
DEF Press Release
Dry Eye Foundation Applauds Breakthrough Investigation of OTC Eye Drop Safety Issues
DEF Press Release

Bloomberg Businessweek’s “No Testing, No Inspections: Contaminated Eyedrops Blinded and Killed Americans” story exposes “gaping hole” in regulatory system

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DEF Press Release
Dry Eye Foundation Launches Mermaid Tears™
DEF Press Release
Dry Eye Foundation Launches Mermaid Tears™
DEF Press Release

Fictitious eye drop exposes regulatory shortfalls for over-the-counter drugs

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DEF Press Release
Bloomberg Businessweek: “No Testing, No Inspections: Contaminated Eyedrops Blinded and Killed Americans”
National Press Coverage
Bloomberg Businessweek: “No Testing, No Inspections: Contaminated Eyedrops Blinded and Killed Americans”
National Press Coverage

“The American public should know that nobody’s looking. It’s not the FDA’s fault that they don’t have the resources to do this. But they shouldn’t pretend that they can”

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National Press Coverage
FDA Disclaimers for OTC Eye Drops
Education
FDA Disclaimers for OTC Eye Drops
Education

FDA says they do not approve or review over-the-counter eye drops - but what does this mean? And, is anybody inspecting the factories where OTC drops are made?

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Education
Managed Healthcare Executive: Over 200 Potentially Unsafe Eye Drops Reported to FDA
National Press Coverage
Managed Healthcare Executive: Over 200 Potentially Unsafe Eye Drops Reported to FDA
National Press Coverage

The Dry Eye Foundation reported 205 eye drops to the FDA that were not found in the FDA database.

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National Press Coverage
Vision Monday: Dry Eye Foundation Reports Potentially Unsafe Eye Drops to FDA
National Press Coverage
Vision Monday: Dry Eye Foundation Reports Potentially Unsafe Eye Drops to FDA
National Press Coverage

Includes recommendations from Dr. Brown for patients and doctors who have concerns

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National Press Coverage
Dry Eye Foundation Notifies Authorities of over 200 Potentially Unsafe Eye Drops
DEF Press Release
Dry Eye Foundation Notifies Authorities of over 200 Potentially Unsafe Eye Drops
DEF Press Release

Surge of unregulated eye drops continues on popular e-commerce websites

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DEF Press Release

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