Important Notice | eyesandoptics

Dear Patients and Community Members,

We are committed to keeping you informed about developments that may impact your eye health. Recently, a significant recall has been issued for over-the-counter eye care products due to concerns over manufacturing practices and product sterility.

What Products Are Affected?

The recall involves five ophthalmic solutions produced by BRS Analytical Services, LLC, and distributed by AvKARE. These products were shipped nationwide between May 26, 2023, and April 21, 2025. The affected products include:

Artificial Tears Ophthalmic Solution (NDC# 50268-043-15)
Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15)
Carboxymethylcellulose Sodium Ophthalmic Solution (NDC# 50268-068-15)
Lubricant Eye Drops Solution (NDC# 50268-126-15)
Polyvinyl Alcohol Ophthalmic Solution (NDC# 50268-678-15)

These products were distributed across the United States, though specific retailers have not been disclosed.

Reason for the Recall

The U.S. Food and Drug Administration (FDA) conducted an audit that uncovered deviations from current Good Manufacturing Practice (cGMP) standards at the manufacturing facility. These deviations raise concerns about the sterility and overall quality of the products. While no specific health risks have been confirmed, the FDA warns there is a potential for temporary or medically reversible adverse health effects.

What Should You Do?

If you have any of the listed products:

Stop Using Them Immediately – Discontinue use to avoid potential health risks.
Check Product Details – Verify the National Drug Code (NDC) numbers and expiration dates on your products.
Dispose of the Products Safely – Follow local guidelines for disposing of medications.
Contact AvKARE for Returns – You can complete a return form available on AvKARE's website and submit it via fax to 931-292-6229 or email to customerservice@avkare.com. AvKARE will issue a full credit, including shipping costs, for returned products.

Reporting Adverse Events

If you experience any adverse effects after using these products, report them to the FDA’s MedWatch Adverse Event Reporting program. You can submit a report online or by mail/fax.