Recalls / Class II
Class IID-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)
- Brand name
- Tiglutik
- Generic name
- Riluzole
- Active ingredient
- Riluzole
- Route
- Oral
- NDC
- 70726-0303
- FDA application
- NDA209080
- Affected lot / code info
- LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
Why it was recalled
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Recalling firm
- Firm
- ITF PHARMA INC
- Manufacturer
- EDW PHARMA, INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 850 Cassatt Rd, N/A, Berwyn, Pennsylvania 19312-2701
Distribution
- Quantity
- 1,792 bottles
- Distribution pattern
- Distributed to one distributor in TN who may have further distributed.
Timeline
- Recall initiated
- 2023-10-20
- FDA classified
- 2023-11-21
- Posted by FDA
- 2023-11-29
- Terminated
- 2025-01-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0115-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.