Class II Recall

ITF PHARMA INC

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)
Reason
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Classification
Class II
Status
Terminated
Lot
LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.