Exact FDA event identifier

Event 77117

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

Event summary

Timeline bucket: April 26, 2017
Product types: Drug
Classifications: Class III
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

Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20

D-0868-2017

Recall number: D-0868-2017
Initiated: April 26, 2017
Classification: Class III
Status: Terminated
Recalling firm: Sandoz Inc
Quantity: 4,464 bottles

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 Drug; Clavulanic Acid

Code information

Lot FP8735, 8/2017

Distribution pattern

NY, OH