Unapproved Eye Drops Lawsuit

Note: This case is closed. Berger Montague is no longer accepting clients for this case.

Recently, the FDA sent a letter to eight eye drop manufacturers warning them that their products were illegal and adulterated. These manufacturers include Walgreens, CVS, Boiron, DR Vitamin Solutions, OcluMed, Similasan, and TRP Company. 

Summary of the FDA’s Eye Drop Warning

The FDA gave these companies 15 days to respond with a plan of action, threatening legal action if corrections weren’t made. The FDA also issued an import alert in an attempt to keep these drops from entering the country. 

The two main issues can be summarized as illegal marketing and harmful ingredients:

Illegal Marketing

Part of the FDA’s warning lies in the dishonest marketing and claims. For instance, Walgreens and CVS declared their various pink eye relief drops could also treat styes, allergies, and pink eye — all without FDA approval. CVS, Walgreens, and others claimed their drops could treat a variety of ailments, including glaucoma, cataracts, conjunctivitis (pink eye), and more without FDA approval which would be illegal marketing. 

Drug wholesaler DR Vitamin Solutions, based out of Fort Worth, Texas, was cited by the FDA for their drops claiming to treat cataracts. These drops were found to contain N-acetyl-carnosine (NAC) which has not been proven to treat that condition. 

What Eye Drops Could Be Included?

According to the FDA and similar experts, the drops below could be included in a defective drugs & medical devices case. With many of the manufacturers being famous country-wide, there’s a good chance you might have come across these in a store aisle — or in your medicine cabinet. 

The affected products could include:

1. Boiron

• Boiron Optique 1 Eye Drops

2. CVS

• CVS Health Pink Eye Relief Eye Drops

3. DR Vitamins LLC

• Vision Clarity Eye Drops
• Life Extension Brite Eyes III
• Can-C Eye Drops
• Longevity Science Visual Ocuity

4. Natural Ophthalmics, Inc.

• Women’s Tear Stimulation Dry Eye Drops 
• Allergy Desensitization Eye Drops 
• Ortho-K Thin (Daytime) Eye Drops 
• Ortho-K Thick (Night) Eye Drops 
• Tear Stimulation Forté Dry Eye Drops
• Cataract Eye Drops with Cineraria 

5. OcluMed LLC 

• OcluMed Eye Drops

6. Similasan (CGMP violations cited in FDA’s letter)

• Similasan Dry Eye Relief
• Similasan Allergy Eye Relief
• Similasan Kids Allergy Eye Relief
• Similasan Red Eye Relief
• Similasan Pink Eye Relief
• Similasan Kids Pink Eye Relief
• Similasan Aging Eye Relief
• Similasan Computer Eye Relief
• Similasan Stye Eye Relief
• Similasan Pink Eye Nighttime Gel
• Similasan Dry Eye Nighttime Gel

7. TRP Company (CGMP violations cited in FDA’s letter)

• Dryness Relief
• Pink Eye Relief
• Allergy Eyes Relief
• Red Eye Relief
• Eye Strain Relief
• Eye Lid Relief
• Aging Eye Relief
• Blur Relief
• Floaters Relief
• Twitching Relief
• Stye Relief

8. Walgreens (CGMP violations cited in FDA’s letter)

• Walgreens Allergy Eye Drops
• Walgreens Stye Eye Drops 
• Walgreens Pink Eye Drops

The FDA recommends that anyone who has used these drops speak to a healthcare provider.