FDA Recall D-0360-2019
Results RNA, LLC · Orem, UT
Class I — life-threatening Terminated 777 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Recall record
- Recall number
D-0360-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Nationwide within the United States
- Recall initiated
- 2018-12-14
- Classified by FDA Center
- 2019-01-14
- FDA published
- 2018-12-26
- Terminated
- 2021-01-29
- Recalling firm
- Results RNA, LLC
- Firm location
- Orem, UT