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…

Recall date

October 20, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0115-2024

FDA classification

Class II

Brand / firm

ITF PHARMA INC

Sold / distributed

Distributed to one distributor in TN who may have further distributed.

Why it was recalled

Failed Viscosity Specifications: Out-of-specification test results for viscosity

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)