October 2023 FDA Recall Tiglutik by Itf Pharma Inc
D-0115-2024 - Failed Viscosity Specifications

This Class II drug recall was voluntarily initiated by Itf Pharma Inc on October 20, 2023 for the product Tiglutik. The FDA reported the reason for recall as failed viscosity specifications. The product was distributed in Distributed to one distributor in TN who may have further distributed. and the recall is currently terminated.

Recall Number: D-0115-2024

Reason for Recall
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Initiated
10-20-2023
Reported
11-29-2023
Quantity
1,792 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93278
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ITF PHARMA INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to one distributor in TN who may have further distributed.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-28-2025
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026

Affected Packages Involved in this Recall

70726-0303-2 Tiglutik
70726-0303-1 Tiglutik