Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX o...
FDA Recall #D-0115-2024 — Class II — October 20, 2023
Product Description
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)
Reason for Recall
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Recalling Firm
ITF PHARMA INC — Berwyn, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,792 bottles
Distribution
Distributed to one distributor in TN who may have further distributed.
Code Information
LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated