Lubrisine Eye Drops Recall: Sterility Concerns And Undeclared Ingredients

A recall has been issued for Lubrisine Eye Drops, after an inspection determined that an undisclosed ingredient may have been included in the product, and it may have been manufactured in a way that was not fully sterile. 

The FDA announced a Lubrisine Eye Drop recall on December 31, indicating that non-sterile manufacturing processes may result in a risk of eye infections and vision loss.

In addition, the eye drops may contain colloidal silver, which could result in permanent discoloration of the conjunctiva following exposure over an extended period of time. There have been no reports of side effects or illnesses related to the recalled eye drops.

The recalled Lubrisine Eye Drops are packaged in single 1 ounce dropper bottles with the UPC code 9238230723. Products are identified by the lot number located on the bottom of the bottle. The affected products include all lots manufactured from May 12, 2012, forward. The date of manufacture is located on the bottom of the bottle.

Lubrisine eye drops were distributed worldwide and nationally through doctors, internet distributors, the company’s website, and wholesale and retail customers.

Results RNA announced the recall to distributors and customers by email on December 14, 2018. The recall notice instructed users to return units of the eye drops to receive a refund.

Any customers currently using the eye drops should stop using the product immediately to prevent any unwanted side effects.

Customers with questions are instructed to send an email to customercare@lubrisine.com. They can also call 203-290-2992.

Side effects or adverse reactions related to the use of Lubrisine eye drops should be reported to the FDA’s MedWatch Adverse Event Reporting Program immediately.