Exact FDA event identifier

Event 84992

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

Event summary

Timeline bucket: January 28, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: NCS Healthcare of Kentucky 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

Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.

D-0850-2020

Recall number: D-0850-2020
Initiated: January 28, 2020
Classification: Class II
Status: Terminated
Recalling firm: NCS Healthcare of Kentucky Inc
Quantity: 6929 blister cards

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.

Code information

Lot #: 8170-9004, Exp 01/2020

Distribution pattern

Nationwide in the USA.