Exact FDA event identifier

Event 91390

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

Event summary

Timeline bucket: December 22, 2022
Product types: Drug
Classifications: Class II
Statuses: Completed
Recalling firm wording: AVKARE LLC

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 Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

D-0091-2023

Recall number: D-0091-2023
Initiated: December 22, 2022
Classification: Class II
Status: Completed
Recalling firm: AVKARE LLC
Quantity: 1237 cartons

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 specifications: Out of specification for unknown impurities.

Code information

Lot#: 43313, 43342, Exp 12/2023

Distribution pattern

USA Nationwide