Lubrisine eye drops recalled over undeclared excipient

Recall date

December 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Results RNA, LLC recalls Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distribute…

Recall number

D-0360-2019

FDA classification

Class I

Brand / firm

Results RNA, LLC

Sold / distributed

Nationwide within the United States

Why it was recalled

Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4