Exact FDA event identifier

Event 76077

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

Event summary

Timeline bucket: December 22, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Sandoz Incorporated

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

Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

D-0236-2017

Recall number: D-0236-2017
Initiated: December 22, 2016
Classification: Class II
Status: Terminated
Recalling firm: Sandoz Incorporated
Quantity: 96 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 specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)

Code information

Lot GG1539

Distribution pattern

MS and OH.