D-0115-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 29, 2023
- Initiation Date
- October 20, 2023
- Termination Date
- January 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,792 bottles
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)
Reason for Recall
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Distribution Pattern
Distributed to one distributor in TN who may have further distributed.
Code Information
LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026