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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62004

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

Open FDA event record

Event summary

Timeline bucket
March 08, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Shionogi 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

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

Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01

D-1398-2012
Recall number
D-1398-2012
Initiated
March 08, 2012
Classification
Class II
Status
Terminated
Recalling firm
Shionogi Inc.
Quantity
7230 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 USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point

Code information

Lot number: 2021956, Exp; 01/2013

Distribution pattern

PA

Field note

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