FDA Recalls SANDIMMUNE Oral Solution Due to Crystallization
Novartis Pharmaceuticals is recalling SANDIMMUNE Oral Solution (cyclosporine 100 mg/mL) due to crystallization found in bottles. The affected lots were distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which warrants a Severe rating (score 4) per regulatory criteria. No illnesses or deaths have been reported; however, the FDA's Class I classification indicates a serious hazard to health.
Plain-English summary
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL is being recalled. The medication in affected bottles was determined to contain crystallization.
The recall involves 6,997 bottles distributed nationwide within the United States. The affected lot numbers are FX001500 and FX001582, with expiration date 09/30/2024. The medication is manufactured by DELPHARM Huningue S.A.S. in Huningue, France and distributed by Novartis Pharmaceuticals Corporation in East Hanover, New Jersey. The National Drug Code (NDC) is 0078-0110-22.
This is an FDA Class I recall. Additional information is available from the FDA at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls using recall number D-0144-2024.
The recalled product
- 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
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Category
- Drug
- Hazard
- Affected units
- 6,997
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: FX001500
- FX001582
- Exp. 09/30/2024
Distribution
Distributed nationwide across the United States.
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