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Recall Observatory FDA recall evidence

Drug product

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

October 20, 2023

Class II

Product summary

Firm
ITF PHARMA INC
Event
Event 93278
Status
Terminated
Classification
Class II
Quantity
1,792 bottles
Official record key
drug-enforcement:D-0115-2024

Official wording

Reason: 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.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification