FDA recall D-0360-2019

Product

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2018-12-14

Report date

2018-12-26

Termination date

2021-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orem, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0360-2019