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FDARecalled Nov 29, 2023 · #D-0115-2024

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 70726-030...

Hazard

Class II — temporary health risk

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Description

Failed Viscosity Specifications: Out-of-specification test results for viscosity Classification: Class II Distribution: Distributed to one distributor in TN who may have further distributed.

Product details

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)
Type
Drugs
Manufacturer
ITF PHARMA INC
Model numbers
2231901
UPCs