Exact FDA event identifier

Event 81742

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 14, 2018
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Results RNA, LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

Recall number: D-0360-2019
Initiated: December 14, 2018
Classification: Class I
Status: Terminated
Recalling firm: Results RNA, LLC
Quantity: 10,297 bottles

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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