ITF PHARMA INC: Drug Recall
Recall #D-0115-2024 · 10/20/2023
Class II: Risk
Recall Details
- Recall Number
- D-0115-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- ITF PHARMA INC
- Status
- Terminated
- Date Initiated
- 10/20/2023
- Location
- Berwyn, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,792 bottles
Reason 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)
Distribution Pattern
Distributed to one distributor in TN who may have further distributed.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.