Lubrisine eye drops — Class I drug recall D-0360-2019
Terminated recall by Results RNA, LLC, reported 2018-12-26, distributed nationwide. Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloi
| Recall number | D-0360-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Results RNA, LLC, Orem, UT, United States |
| Recall initiated | 2018-12-14 |
| Classified | 2019-01-14 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2021-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 10,297 bottles |
| Reason classes | undeclared allergen, sterility |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0360-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.