Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manuf...
FDA Recall #D-0360-2019 — Class I — December 14, 2018
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
Recalling Firm
Results RNA, LLC — Orem, UT
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
10,297 bottles
Distribution
Nationwide within the United States
Code Information
All Lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated