Exact FDA event identifier

Event 81719

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

Event summary

Timeline bucket: December 10, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Gordon Laboratories

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

Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.

D-0338-2019

Recall number: D-0338-2019
Initiated: December 10, 2018
Classification: Class II
Status: Terminated
Recalling firm: Gordon Laboratories
Quantity: 1,155 boxes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: contains higher levels of Iron than labeled.

Code information

Batch #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19.

Distribution pattern

Nationwide in the USA.