Exact FDA event identifier

Event 90091

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

Event summary

Timeline bucket: April 28, 2022
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Viatris 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

Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.

D-0854-2022

Recall number: D-0854-2022
Initiated: April 28, 2022
Classification: Class II
Status: Terminated
Recalling firm: Viatris Inc
Quantity: 110 bottles

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 Dissolution Specifications: low out of specification results for dissolution.

Code information

Lot #: DX7983, exp. date 02/28/2023

Distribution pattern

Product was distributed nationwide in the USA