D-0360-2019 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 26, 2018
- Initiation Date
- December 14, 2018
- Termination Date
- January 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,297 bottles
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
Distribution Pattern
Nationwide within the United States
Code Information
All Lots