PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: December 26, 2018 Initiated: December 14, 2018 #D-0360-2019

Product Description

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

Details

Recalling Firm
Results RNA, LLC
Units Affected
10,297 bottles
Distribution
Nationwide within the United States
Location
Orem, UT

Frequently Asked Questions

What product 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. Recalled by Results RNA, LLC. Units affected: 10,297 bottles.
Why was this product recalled?
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Which agency issued this recall?
This recall was issued by the FDA Drug on December 26, 2018. Severity: Critical. Recall number: D-0360-2019.