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

Source: FDA Drug Recalls
Wed Jan 2, 2019 8:08PM

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

Original Article


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