Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for I
Summary
The FDA issued a Class II for Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/3 by ITF PHARMA INC. Reason: Failed Viscosity Specifications: Out-of-specification test results for viscosity.
Details
Source
Drug Recall
External ID
D-0115-2024
Action Date
2023-11-29
Status
Terminated
Category
drug
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)
Lot/Code Info: LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
Quantity Affected: 1,792 bottles
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-20
Company
Berwyn, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 38 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ITF PHARMA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ITF PHARMA INC have FDA actions?
This is the only FDA action we have on record for ITF PHARMA INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0115-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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