Exact FDA event identifier

Event 77018

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

Event summary

Timeline bucket: April 17, 2017
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Fagron, 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

Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.

D-0695-2017

Recall number: D-0695-2017
Initiated: April 17, 2017
Classification: Class III
Status: Terminated
Recalling firm: Fagron, Inc
Quantity: Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Error on Declared Strength: Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.

Code information

Lot #: 17C01-U07-036096, Exp. 5/1/2020

Distribution pattern

Nationwide within US