Recalls / Class I
Class ID-0144-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Affected lot / code info
- Lot #: FX001500, FX001582, Exp. 09/30/2024
Why it was recalled
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Recalling firm
- Firm
- Novartis Pharmaceuticals Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Health Plz, East Hanover, New Jersey 07936-1016
Distribution
- Quantity
- 6,997 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-11-22
- FDA classified
- 2023-12-07
- Posted by FDA
- 2023-12-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0144-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.