Exact FDA event identifier

Event 85072

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

Event summary

Timeline bucket: November 15, 2019
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Grato Holdings, Inc.

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

Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1

D-1049-2020

Recall number: D-1049-2020
Initiated: November 15, 2019
Classification: Class III
Status: Terminated
Recalling firm: Grato Holdings, Inc.
Quantity: 659 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling mix-up - Indications on product label are incorrect.

Code information

Lot # Z56673

Distribution pattern

U.S.A. Nationwide, Israel