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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94519

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 30, 2024
Product types
Drug
Classifications
Class II
Statuses
Completed
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

Complete imported group

Every recalled product in this event

2 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 2

Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10

D-0602-2024
Recall number
D-0602-2024
Initiated
April 30, 2024
Classification
Class II
Status
Completed
Recalling firm
Viatris Inc
Quantity
12,691 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #: 8147040; Exp. June 2024 Lot #: 8163764; Exp. March 2025

Distribution pattern

U.S. Nationwide

drug · product 2 of 2

Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10

D-0603-2024
Recall number
D-0603-2024
Initiated
April 30, 2024
Classification
Class II
Status
Completed
Recalling firm
Viatris Inc
Quantity
3,694 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot#: 8147041; Exp. June 2024 Lot#: 8163765; Exp. March 2025

Distribution pattern

U.S. Nationwide