FDAFDA · Food and drugs·Recall number D-0115-2024
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)
Published November 29, 2023 · Recall initiated: October 20, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Viscosity Specifications: Out-of-specification test results for viscosity
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIGLUTIK
- Manufacturer
- ITF PHARMA INC
- Distributor
- Distributed to one distributor in TN who may have further distributed.
- Lot
- LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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