CLASS I Drug recall · Reported 26 Dec 2018 · FDA Enforcement Report
Lubrisine eye drops (polyethylene glycol recalled by Results RNA
Results RNA is recalling Lubrisine eye drops (polyethylene glycol 400 4% and Propylene glycol 3%), Manufactured, distributed nationwide in the US. The recall was initiated on 14 Dec 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0360-2019
- FDA event ID
- 81742
- Recalling firm
- Results RNA, Orem, UT
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 14 Dec 2018
- FDA classified
- 14 Jan 2019
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 14 Dec 2018 | Recall initiated by company | |
| 26 Dec 2018 | Published in enforcement report | +12 days |
| 14 Jan 2019 | Classified by FDA | +19 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Lubrisine eye drops (polyethylene glycol 400 4% and Propylene glycol 3%), Manufactured recalled?
Yes. Results RNA recalled Lubrisine eye drops (polyethylene glycol 400 4% and Propylene glycol 3%), Manufactured on 14 Dec 2018. The recall is Class I and its status is Terminated. Recall number D-0360-2019.
Why was it recalled?
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Which lots are affected?
All Lots
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.