Drug 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
D-0360-2019
Product summary
- Firm
- Results RNA, LLC
- Event
- Event 81742
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10,297 bottles
- Official record key
drug-enforcement:D-0360-2019
Official wording
Reason: Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Code information: All Lots
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Sterility