Why it was recalled
Failed Viscosity Specifications: Out-of-specification test results for viscosity
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 numbers, UPCs & expiration codes
LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
Where it was sold
Distributed to one distributor in TN who may have further distributed.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0115-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 20, 2023
- FDA report date
- Nov 29, 2023
- Quantity
- 1,792 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ITF PHARMA INC
Original FDA data
Every field from FDA enforcement report D-0115-2024, exactly as published.
Show all FDA fields
- City
- Berwyn
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 93278
- Address
- 850 Cassatt Rd
- Code information
- LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026
- Postal code
- 19312-2701
- Report date
- Nov 29, 2023
- Product type
- Drugs
- Recall number
- D-0115-2024
- Classification
- Class II
- Recalling firm
- ITF PHARMA INC
- Product quantity
- 1,792 bottles
- Termination date
- Jan 28, 2025
- Reason for recall
- Failed Viscosity Specifications: Out-of-specification test results for viscosity
- Voluntary / mandated
- Voluntary: Firm initiated
- 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)
- Distribution pattern
- Distributed to one distributor in TN who may have further distributed.
- Recall initiation date
- Oct 20, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2023