Exact FDA event identifier

Event 66554

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

Event summary

Timeline bucket: October 11, 2013
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Sandoz 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

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,

D-393-2014

Recall number: D-393-2014
Initiated: October 11, 2013
Classification: Class II
Status: Terminated
Recalling firm: Sandoz Inc
Quantity: 2,491 bottles of 100 tablets each

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent; Hydrochlorothiazide at the 9 month time point.

Code information

Lot CU0856

Distribution pattern

Nationwide