Class I
Ongoing
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.
This recall is currently active, issued September 27, 2023. It was issued by Novartis Pharmaceuticals Corp..
- Company
- Novartis Pharmaceuticals Corp.
- Recall Initiated
- September 8, 2023
- Posted
- September 27, 2023
- Recall Number
- D-1174-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1272 bottles
- Firm Location
- East Hanover, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Distribution
Nationwide in the USA
Lot / Code Info
FX001691, Exp. 12/31/2025
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