ITF PHARMA INC recalls Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for I
Recalled November 29, 2023 · FDA recall D-0115-2024 · ITF PHARMA
Hazard
Failed Viscosity Specifications: Out-of-specification test results for viscosity · FDA Class II
Units
1,792 bottles
Sold at
Distributed to one distributor in TN who may have further distributed.
Description
Failed Viscosity Specifications: Out-of-specification test results for viscosity
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)
Manufacturer(s)
ITF PHARMA INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →