Exact FDA event identifier

Event 80878

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

Event summary

Timeline bucket: February 07, 2019
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: ACP Nimble Buyer, 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

Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37

D-0514-2019

Recall number: D-0514-2019
Initiated: February 07, 2019
Classification: Class III
Status: Terminated
Recalling firm: ACP Nimble Buyer, Inc.
Quantity: 58,176 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.

Code information

Lot #: 1009431, 1009507, Exp. 08/2020; 1009886, Exp. 09/2020

Distribution pattern

Nationwide within the United States