FDA-Drug2023-11-29Class II
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)
ITF PHARMA INC
Hazard
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Sold states
Distributed to one distributor in TN who may have further distributed.
Affected count
1,792 bottles
Manufactured in
850 Cassatt Rd, N/A, Berwyn, PA, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0115-2024Don't want to check this manually?
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