December 2018 FDA Recall Drug by Results Rna, Llc
D-0360-2019 - Lack of Sterility Assurance and Incorrect/Undeclared excipient

This Class I drug recall was voluntarily initiated by Results Rna, Llc on December 14, 2018 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance and incorrect/undeclared excipient. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0360-2019

Reason for Recall
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Initiated
12-14-2018
Reported
12-26-2018
Quantity
10,297 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81742
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Results RNA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# All Lots