Why it was recalled
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Product description
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
Lot numbers, UPCs & expiration codes
Lot #: FX001500, FX001582, Exp. 09/30/2024
Where it was sold
Nationwide within the United States
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-0144-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Nov 22, 2023
- FDA report date
- Dec 13, 2023
- Quantity
- 6,997 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corporation
Original FDA data
Every field from FDA enforcement report D-0144-2024, exactly as published.
Show all FDA fields
- City
- East Hanover
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93464
- Address
- 1 Health Plz
- Code information
- Lot #: FX001500, FX001582, Exp. 09/30/2024
- Postal code
- 07936-1016
- Report date
- Dec 13, 2023
- Product type
- Drugs
- Recall number
- D-0144-2024
- Classification
- Class I
- Recalling firm
- Novartis Pharmaceuticals Corporation
- Product quantity
- 6,997 bottles
- Reason for recall
- Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 22, 2023
- Initial firm notification
- Letter
- Center classification date
- Dec 7, 2023