Drug 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)
D-0115-2024
Product summary
- Firm
- ITF PHARMA INC
- Event
- Event 93278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,792 bottles
- Official record key
drug-enforcement:D-0115-2024
Official wording
Reason: Failed Viscosity Specifications: Out-of-specification test results for viscosity
Code information: LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
Distribution pattern: Distributed to one distributor in TN who may have further distributed.
Derived failure modes
-
Potency or specification failure
Out-of-specification