Berwyn, PA, United States
ITF PHARMA INC recalls
1 recall recorded since 2018, most recently on 20 October 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 20 October 2023
- Terminated
- 28 January 2025
- Reason
- Failed Viscosity Specifications: Out-of-specification test results for viscosity
- Distribution
- Distributed to one distributor in TN who may have further distributed.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 70726-0303-2 (bottle)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.