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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93278

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

Open FDA event record

Event summary

Timeline bucket
October 20, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ITF PHARMA 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

Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle)

D-0115-2024
Recall number
D-0115-2024
Initiated
October 20, 2023
Classification
Class II
Status
Terminated
Recalling firm
ITF PHARMA INC
Quantity
1,792 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 Viscosity Specifications: Out-of-specification test results for viscosity

Code information

LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026

Distribution pattern

Distributed to one distributor in TN who may have further distributed.