Class II
Terminated
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)
- Company
- Itf Pharma Inc
- Recall Initiated
- October 20, 2023
- Posted
- November 29, 2023
- Recall Number
- D-0115-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,792 bottles
- Firm Location
- Berwyn, PA, United States
Reason for Recall
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Distribution
Distributed to one distributor in TN who may have further distributed.
Lot / Code Info
LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
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