Recalling firm
ITF PHARMA INC
Product type
Drug
Status
Terminated
Report date
2023-11-29
Distribution
Distributed to one distributor in TN who may have further distributed.
Firm state
PA
Product quantity
1,792 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Product description
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)
Code / lot info
LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.