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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92975

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

Open FDA event record

Event summary

Timeline bucket
September 08, 2023
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Novartis Pharmaceuticals Corp.

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

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.

D-1174-2023
Recall number
D-1174-2023
Initiated
September 08, 2023
Classification
Class I
Status
Ongoing
Quantity
1272 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Code information

FX001691, Exp. 12/31/2025

Distribution pattern

Nationwide in the USA