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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93464

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

Open FDA event record

Event summary

Timeline bucket
November 22, 2023
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Novartis Pharmaceuticals Corporation

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-0144-2024
Recall number
D-0144-2024
Initiated
November 22, 2023
Classification
Class I
Status
Ongoing
Quantity
6,997 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

Lot #: FX001500, FX001582, Exp. 09/30/2024

Distribution pattern

Nationwide within the United States