FDA recall D-1174-2023

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.

Reason for recall

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2023-09-08

Report date

2023-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Hanover, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1174-2023