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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78169

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

Open FDA event record

Event summary

Timeline bucket
September 25, 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

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

Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.

D-1179-2017
Recall number
D-1179-2017
Initiated
September 25, 2017
Classification
Class III
Status
Terminated
Recalling firm
Sandoz Inc
Quantity
13,435 shrink wrap packs

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.

Code information

Lot: GH8254, Exp 06/19

Distribution pattern

Nationwide in the USA and Puerto Rico