Reported Nov 29, 2023 · Terminated
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.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ITF PHARMA INC · 850 Cassatt Rd · Berwyn, PA · 19312-2701
Is this the product you have?
- 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 NDC70726-0303-1 (carton) and 70726-0303-2 (bottle)
- Lot codes and dates
LOT# 2231901Exp. 11/30/20252307901Exp. 03/31/2026
- Amount recalled
- 1,792 bottles
Where it was sold
Why it was recalled
Failed Viscosity Specifications: Out-of-specification test results for viscosity
This product could cause temporary or reversible health problems — stop using it.
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