Recalling firm
Novartis Pharmaceuticals Corporation
Product type
Drug
Status
Ongoing
Report date
2023-12-13
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
6,997 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
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
Code / lot info
Lot #: FX001500, FX001582, Exp. 09/30/2024
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.