# FDA recall D-0115-2024

> **ITF PHARMA INC** · Class II · drug recall initiated 2023-10-20.

## 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)

## 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.

## Key facts

- **Recall number:** D-0115-2024
- **Recalling firm:** ITF PHARMA INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-10-20
- **Report date:** 2023-11-29
- **Termination date:** 2025-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berwyn, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0115-2024

## Citation

> MORVS. FDA recall D-0115-2024. Retrieved 2026-10-13 from https://api.morvs.ai/recall/D-0115-2024. Source: US FDA. Licensed CC0.

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