Medication Monitor



Generic Name (Trade Name—Company)
Notes
January 11, 2019

Lubricating eye drops

(Lubrisine Eye Drops—Results RNA)
Sterility concerns, undeclared colloidal silver prompt recall

On December 31, 2018, Results RNA announced a voluntary recall of Lubrisine Eye Drops because a recent FDA inspection found the product contains undeclared colloidal silver and was manufactured using practices that do not support its sterility.

Use of a nonsterile 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. 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 1-oz dropper bottle with the UPC code 9238230723. The affected lots include all those manufactured from May 12, 2012, forward. This date of manufacture is located on the bottom of the bottle.

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

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

As of the announcement date, Results RNA had not received any reports of adverse events or illnesses related to this recall.