FDA recall D-0115-2024

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 for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2023-10-20

Report date

2023-11-29

Termination date

2025-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berwyn, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0115-2024