Tiglutik Liquid
FDA Recall NDC 70726-0303
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tiglutik (NDC 70726-0303). A significant event, classified as Class II, was initiated on Oct 20, 2023 by Edw Pharma, Inc. The reported reason for this action was: "Failed Viscosity Specifications: Out-of-specification test results for viscosity"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Oct 20, 2023
Nov 29, 2023
1,792 bottles
Recall Profile & Regulatory Data
Event ID
93278
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
ITF PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to one distributor in TN who may have further distributed.
Termination Date
Jan 28, 2025
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)
Batch or Lot Expiration Information
Lot# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
Affected Packages Involved in this Recall
70726-0303-2Product
70726-0303-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
