Exact FDA event identifier

Event 85704

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

Event summary

Timeline bucket: May 15, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: TRIOVA PHARMACEUTICALS 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

Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02

D-1284-2020

Recall number: D-1284-2020
Initiated: May 15, 2020
Classification: Class II
Status: Terminated
Recalling firm: TRIOVA PHARMACEUTICALS LLC
Quantity: 210 grams

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed impurities/ degradation specifications: Out of specification for organic impurities.

Code information

Lot #:17010401181119190927, EXP 12/2020, 1701040118111919092725200122, EXP.12/2020

Distribution pattern

U.S.A. Nationwide