Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Results RNA LLC Issues Voluntary Worldwide/Nationwide Recall of Lubrisine Eye Drops Due to Manufacturing Sterility Concerns and Undeclared Colloidal Silver

For Immediate Release

December 31, 2018

Contact

Consumers

Results RNA LLC
Sam Gossett
customercare@lubrisine.com
203-290-2992

Announcement

Results RNA LLC is voluntarily recalling Lubrisine Eye Drops to the healthcare practitioner, retail or consumer level. This product, in a recent FDA inspection, was found to be manufactured using practices that do not support its sterility and contained undeclared colloidal silver.

Use of a non-sterile eye drop could result in a potentially sight threatening eye infection. Exposure to colloidal silver, over an extended period of time, could result in permanent discoloration of the conjunctiva. Results RNA has not received any reports of adverse events related to this recall. No illnesses have been reported regarding the product to date. The products can be identified by the following label and the lot number located on the bottom of the bottle.

The product is used to support lubrication of dry eyes and is packaged in a single 1oz dropper bottle with the UPC code 9238230723. The affected Lubrisine Eye Drops lots include all lots manufactured from May 12, 2012 forward. This date of manufacture is located on the bottom of the bottle.

Lubrisine Eye Drops were distributed Worldwide/Nationwide through healthcare practitioners, internet distributors, and the company’s website to wholesale and retail customers.

Results RNA LLC notified its distributors and customers by email on December 14, 2018 announcing the Lubrisine Eye Drops recall with specific directions for returning all units of Lubrisine Eye Drops and how to obtain a refund applicable to the recalled product. Consumers with Lubrisine Eye Drops should stop using the product immediately.

Distributors, healthcare providers and consumers with questions regarding this recall can contact Results RNA LLC as follows:

Email
Submit all inquiries to customercare@lubrisine.com  

Phone
Call: 203-290-2992
Available hours: 8am – 5pm MST

Mail
Results RNA, LLC
P.O. Box 93
New Hartford, CT 06057

Website: disclaimer iconwww.lubrisine.com

Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Product Photos

“Lubrisine eye drops, Extra Strength, 1 FL OZ”

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