Exact FDA event identifier

Event 77196

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

Event summary

Timeline bucket: April 19, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Gentell, 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

Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40

D-0866-2017

Recall number: D-0866-2017
Initiated: April 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Gentell, Inc
Quantity: 65 gallons

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations; product may not meet cGMP requirements

Code information

Product Code GEN-23240

Distribution pattern

Nationwide and Puerto Rico